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  • Dual-action drug produces positive results in patients with advanced neuroendocrine tumors, trial finds

    Dual-action drug produces positive results in patients with advanced neuroendocrine tumors, trial finds

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    Newswise — Boston – A drug that simultaneously strikes cancer cells’ growth circuits and pipeline to the bloodstream produced encouraging results in a clinical trial involving patients with advanced neuroendocrine tumors, according to a study led by Dana-Farber Cancer Institute investigators.

    Jennifer Chan, MD, MPH, director of the Program in Carcinoid and Neuroendocrine Tumors at Dana-Farber, will present the findings of the CABINET trial at the annual European Society for Medical Oncology (ESMO) Congress on October 22, 2023, in Madrid, Spain. Chan is first author on the study. Jeffrey Meyerhardt, MD, MPH, co-director of the Colon and Rectal Cancer Center at Dana-Farber, is senior author.

    Patients treated with the drug, cabozantinib, survived significantly longer with no worsening of their disease than patients who received a placebo. The results suggest cabozantinib, which has been approved by the U.S. Food and Drug Administration for some patients with renal cell carcinoma, hepatocellular carcinoma, or thyroid cancer, can benefit patients with neuroendocrine tumors that continue to grow and spread after previous treatment, researchers say.

    More than 12,000 people in the United States are diagnosed with a neuroendocrine tumor each year. The tumors begin in neuroendocrine cells – which have characteristics of nerve and hormone-producing cells – and can arise in multiple sites in the body, most often in the gastrointestinal tract, lungs, and pancreas. Treatments may include surgery, targeted therapy, peptide receptor radionuclide therapy, chemotherapy, or other local treatment approaches depending on the location and stage of the cancer. For patients whose cancer continues to grow and spread after these treatments, better options are urgently needed.

    “Although advances have been made in recent years, there remains a critical need for new and effective therapies for patients with advanced neuroendocrine tumors, particularly patients whose cancer has progressed on currently available options,” said Chan. “Targeting angiogenesis and other growth factor pathways with cabozantinib represents a novel treatment strategy.”

    Cabozantinib undermines tumor cells in multiple ways. It blocks the receptor for VEGF, a protein used to tap into the body’s blood supply, as well as other receptors including c-MET, AXL, and RET that are key to tumor cell survival and metastasis.

    The study enrolled 197 patients with advanced extra-pancreatic neuroendocrine tumors (which arise outside the pancreas) and 93 patients with pancreatic neuroendocrine tumors. Patients were enrolled at sites within the National Cancer Institute (NCI)-funded National Clinical Trials Network (NCTN). Two-thirds of the participants were randomly assigned take a 60 mg cabozantinib pill daily, and the others were given a placebo, or inert pill.

    Researchers measured progression-free survival (PFS) – how long patients lived before their disease worsened – for all participants. At a median follow-up of 13.9 months, the PFS for patients with extra-pancreatic tumors who took cabozantinib was 8.3 months, compared to 3.2 for those who took a placebo. At a median follow-up of 16.7 months, patients with pancreatic tumors who took cabozantinib had a PFS of 11.4 months, compared to 3.0 months for those who took a placebo.

    Side effects of cabozantinib were similar to those found in other studies of the drug. These include hypertension, fatigue, diarrhea, and skin rash.        

    “The results of the CABINET trial are very encouraging,” said Chan. “Cabozantinib significantly improved outcomes in patients with previously treated extra-pancreatic and pancreatic neuroendocrine tumors and may become a new treatment option for patients.”

    The CABINET trial was sponsored by the NCI, part of the National Institutes of Health (U10CA180821, U10CA180882), and was led and conducted by the NCI-funded Alliance for Clinical Trials in Oncology with participation from the NCTN as part of Exelixis’ collaboration with the NCI’s Cancer Therapy Evaluation Program (NCI-CTEP); https://acknowledgments.alliancefound.org.

    ESMO Session Details

    LBA 53: Alliance A021602: Phase III, Double-Blinded Study of Cabozantinib Versus Placebo for Advanced Neuroendocrine Tumors (NET) After Progression on Prior Therapy (CABINET) on Sunday, October 22, 2023, at 2:40 am ET (8:40 CEST) Jennifer Chan, MD, MPH/First Author

    For all ESMO-related media inquiries, call or email Victoria Warren, 617-939-5531, [email protected]. Follow the meeting live on X (Twitter) using the hashtag #ESMO23 and follow Dana-Farber News on X (Twitter) at @DanaFarberNews.

    About Dana-Farber Cancer Institute 

    Dana-Farber Cancer Institute is one of the world’s leading centers of cancer research and treatment. Dana-Farber’s mission is to reduce the burden of cancer through scientific inquiry, clinical care, education, community engagement, and advocacy. Dana-Farber is a federally designated Comprehensive Cancer Center and a teaching affiliate of Harvard Medical School.

    We provide the latest treatments in cancer for adults through Dana-Farber Brigham Cancer Center and for children through Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. Dana-Farber is the only hospital nationwide with a top 5 U.S. News & World Report Best Cancer Hospital ranking in both adult and pediatric care.

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    Dana-Farber Cancer Institute

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  • ESMO: Pre- and post-surgical immunotherapy improves outcomes for patients with operable lung cancer

    ESMO: Pre- and post-surgical immunotherapy improves outcomes for patients with operable lung cancer

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    Newswise — MADRID ― Compared with pre-surgical (neoadjuvant) chemotherapy alone, adding perioperative immunotherapy – given before and after surgery – significantly improved event-free survival (EFS) in patients with resectable early-stage non-small cell lung cancer (NSCLC). Results from the Phase III CheckMate 77T study were presented today at the 2023 European Society for Medical Oncology (ESMO) Congress by researchers from The University of Texas MD Anderson Cancer Center.

    At a median follow-up of 25.4 months, the median EFS with chemotherapy alone was 18.4 months, while the median had not yet been reached for patients receiving perioperative nivolumab, meaning EFS was prolonged significantly over the control group. These results correspond to a 42% reduction in risk of disease progression, recurrence, or death for those receiving the perioperative combination.

    Patients who received the perioperative nivolumab-based regimen also saw significantly higher rates of pathological complete response (pCR), defined as no tumor remaining at surgery, compared with those who received chemotherapy alone (25.3% vs. 4.7%). Rates of major pathological response (MPR), less than or equal to 10% of viable tumor cells remaining at time of surgery, were also higher in patients who received perioperative immunotherapy (35.4% vs. 12.1%).

    “This study builds on the standard-of-care neoadjuvant treatment and supports perioperative nivolumab as an effective approach that reduces the risk of lung cancer relapse,” said principal investigator Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head & Neck Medical Oncology. “These findings add to evidence that the perioperative immunotherapy path gives patients with operable lung cancer an opportunity to live longer without their cancer returning.”

    Roughly 30% of patients diagnosed with NSCLC have operable disease, meaning their tumor can be removed by a surgical operation. While many of these patients can be potentially cured by surgery, more than half will experience cancer recurrence without additional therapy. Chemotherapy given either before or after surgery provides only a minimal survival benefit.

    The randomized, double-blind CheckMate 77T trial, which began in 2019, included more than 450 NSCLC patients over the age of 18 from around the globe. Participants were randomized to treatment with either neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, or neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo

    The data showed no new safety signals with the perioperative nivolumab regimen and is consistent with the known safety profiles of individual agents. Grade 3-4 treatment-related side effects were observed in 32% and 25% of patients receiving the perioperative combination or control therapy, respectively. Surgery-related adverse events occurred in 12% of patients in both treatment arms.

    These findings add to recent success seen with neoadjuvant nivolumab plus chemotherapy in NSCLC. In March 2022, the Phase III CheckMate 816 study led to FDA approval of nivolumab combined with platinum-based chemotherapy.

    “I am enthusiastic about the initial findings of the study,” Cascone said. “Looking ahead, it will be critical to identify patient and disease characteristics that will tell us who can potentially be cured with neoadjuvant immunotherapy only and who will benefit from more intensified treatment strategies.”

    The CheckMate 77T study was sponsored by Bristol Myers Squibb. A full list of co-authors and author disclosures can be found here.

    Read this press release on the MD Anderson Newsroom. 

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    University of Texas MD Anderson Cancer Center

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  • Kidney cancer study shows improved outcomes for patients with advanced disease when treated with belzutifan over everolimus

    Kidney cancer study shows improved outcomes for patients with advanced disease when treated with belzutifan over everolimus

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    Newswise — Boston – Belzutifan significantly reduced the risk of progression of clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer, in patients previously treated with immune checkpoint inhibitors and anti-angiogenic therapies compared with everolimus in a phase 3 clinical trial. The trial, led by Toni K. Choueiri, MD, Director of the Lank Center for Genitourinary Cancer at Dana-Farber Cancer Institute, showed the risk of progression was reduced by 25-26%.

    The results were presented at the annual European Society for Medical Oncology (ESMO) Congress on October 21, 2023, in Madrid, Spain.

    “This is real progress for patients and could lead to approval of this drug for this patient group,” says Choueiri, senior author on the presentation in Madrid.

    Belzutifan, a HIF-2α inhibitor, is currently approved for patients with Von Hippel-Landau (VHL) disease-associated renal cell carcinoma, a form of kidney cancer. The drug was originally investigated and approved for kidney cancer patients with VHL disease because they have inherited a mutation that inactivates the VHL gene, which results in an overabundance of HIF-2α in cells.

    When overabundant in cells, HIF-2α is associated with increased cancer-driving activity, such as cell proliferation, immune evasion, low oxygen levels (called hypoxia), and blood vessel formation (called angiogenesis). Dana-Farber’s William G. Kaelin, Jr., MD, was awarded a Nobel Prize in Physiology or Medicine in 2019 for the discovery of the role HIF-2α in cancer and other diseases.

    “The knowledge we have about hypoxia and angiogenesis in kidney cancer stemmed from this essential pre-clinical research at Dana-Farber,” says Choueiri. “Bringing this knowledge forward to benefit patients is very gratifying.”

    While the mutation that causes VHL disease is inherited, spontaneous mutations that inactivate VHL occur in over 90% of ccRCC tumors, suggesting that a HIF-2α inhibitor might also benefit patients with ccRCC.

    This trial, called LITESPARK-005, enrolled 746 patients with metastatic ccRCC who had progressed after treatment with both an immune checkpoint inhibitor (ICI), such as a PD-1 or PD-L1 inhibitor, and an anti-angiogenic therapy. ICIs and anti-angiogenic medicines have become a standard part of first- and second-line therapies for metastatic ccRCC, though most patients eventually experience disease progression and need additional treatment options.

    Patients were randomized to receive treatment with either belzutifan or everolimus. At the second interim analysis, after a median of 25.7 months, patients taking belzutifan were 26% less likely to have progressed compared with those taking everolimus.

    The overall response rate was also higher with belzutifan, at 22% versus 3.5%, and 13 patients experienced a complete response with belzutifan compared to none with everolimus. Patients taking belzutifan were also less likely to discontinue therapy due to side effects.

    “Importantly, quality of life favored belzutifan,” says Choueiri.

    There was an improvement in overall survival with belzutifan though it was not statistically significant.

    This investigation of monotherapy with belzutifan is part of a broader strategy to learn more about the efficacy and safety of HIF-2α inhibition in RCC. The strategy involves multiple LITESPARK trials examining beluzutifan alone and in combination with other therapies in treatment-naive and pre-treated disease settings. Choueiri also presented updated findings from the phase 2 LITESPARK-003 at the ESMO Congress that showed belzutifan plus cabozantinib showed durable antitumor activity and a safety profile consistent with prior observation previously published in The Lancet Oncology.

    Both trials are sponsored by Merck Sharp & Dohme LLC.

    ESMO Session Details

    LBA 87: Phase 2 LITESPARK-003 Study of belzutifan in combination with cabozantinib for advanced clear cell renal cell carcinoma (ccRCC) will be presented in Proffered Paper Session 2 – Genitourinary tumors, non-prostate on Saturday, October 21, 2023, at 8:45am ET (14:45 CEST) Toni K. Choueiri, MD/First Author

    LBA 88: Belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC): randomized open-label phase 3 LITESPARK-005 study will be presented in Proffered Paper Session 2- Genitourinary tumors, non-prostate on Saturday, October 21, 2023, at 8:55am ET (14:55 CEST) Toni K. Choueiri, MD/Senior Author

    About Dana-Farber Cancer Institute 

    Dana-Farber Cancer Institute is one of the world’s leading centers of cancer research and treatment. Dana-Farber’s mission is to reduce the burden of cancer through scientific inquiry, clinical care, education, community engagement, and advocacy. Dana-Farber is a federally designated Comprehensive Cancer Center and a teaching affiliate of Harvard Medical School.

    We provide the latest treatments in cancer for adults through Dana-Farber Brigham Cancer Center and for children through Dana-Farber/Boston Children’s Cancer and Blood Disorders Center. Dana-Farber is the only hospital nationwide with a top 5 U.S. News & World Report Best Cancer Hospital ranking in both adult and pediatric care.

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    Dana-Farber Cancer Institute

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  • Potato starch supplements could be solution to bone marrow transplant complications

    Potato starch supplements could be solution to bone marrow transplant complications

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    BYLINE: Tessa Roy

    Newswise — Experts at the University of Michigan Health Rogel Cancer Center have found a potential solution for preventing a common and dangerous complication in patients that receive stem cell transplants from a donor’s blood or bone marrow.  

    Approximately 18,000 people per year in the United States are diagnosed with life threatening illnesses, including blood cancers where a blood or bone marrow stem cell transplant from a donor is their best treatment option.

    About 9,000 such transplants are performed yearly in the U.S. 

    When patients receive a stem cell transplant, they get a new immune system from the donor whose job is to attack cells that don’t belong there including cancer cells. 

    Sometimes, however, those donor immune cells (the graft) begin to see the patient’s own body (the host) as unfamiliar and foreign. As a result, the donor cells may attack the patient’s own organs and tissues, causing Graft versus Host Disease. 

    GVHD develops in up to half of patients who receive stem cell transplants from a donor’s blood or bone marrow. It can affect many parts of the body and can range from mild or moderate to more severe and even life threatening.

    The way to prevent and treat GVHD is by using strong medicines to suppress the immune system which can cause patients to get infections which can also be life-threatening. Therefore, while bone marrow and blood stem cell transplants from a donor are lifesaving for many patients with various serious illnesses, the development of GVHD can cause injury or even death and the treatments available for GVHD are risky.  

    Previous research showed that the bacteria that normally live in the intestines and their products can affect whether or not GVHD happens after a transplant. 

    Researchers have found that a food supplement made from potato starch, when given to ten patients who received stem cell transplants from a donor, changed the products of intestinal bacteria in a way that could potentially prevent GVHD from happening.   

    “GVHD is a major limitation to the lifesaving capability of blood or marrow stem cell transplants. It is exciting to think of the prospect of potentially finding a simple, low-cost, and safe approach to mitigating this dangerous complication for patients who need a stem cell transplant, but researching this approach in more patients is still needed to confirm,” said Mary Riwes, D.O., assistant professor of internal medicine and medical director of the inpatient adult stem cell transplant unit of the Medical Directors Partnering to Lead Along with Nurse Managers program.   

    Investigators are currently enrolling more patients for a second phase of this study to determine whether taking potato starch will indeed result in less GVHD after stem cell transplant. Sixty patients undergoing a blood or bone marrow stem cell transplant from a donor who are ten years or older will be randomized to take potato starch or placebo starch in addition to taking all the usual medications for preventing GVHD with 80% receiving potato starch and 20% placebo starch. This phase II clinical trial will help researchers learn whether or not taking potato starch is an effective intervention for preventing GVHD. 

    More information about this Phase II trial can be found on Clinicaltrials.gov identifier: NCT02763033 

    Additional authors include Jonathan L. Golob, John Magenau, Mengrou Shan, Gregory Dick, Thomas Braun, Thomas M. Schmidt, Attaphol Pawarode, Sarah Anand, Monalisa Ghosh, John Maciejewski, Darren King, Sung Choi, Gregory Yanik, Marcus Geer, Ethan Hillman, Costas A. Lyssiotis, Muneesh Tewari and Pavan Reddy

    Funding/disclosures: Thanks to the volunteers who participated in the study and the clinical and research staff of the University of Michigan Bone Marrow Transplant program. This work was supported by the National Heart, Lung, and Blood Institute (grant no. P01 HL149633, P.R., M.T., M.M.R.) which facilitated all bio sample analyses. The funder had no role in the design and analysis of the study. Resistant starch was purchased using institutional startup funds (M.M.R). 

    Paper cited: “Feasibility of a dietary intervention to modify gut microbial metabolism in patients with hematopoietic stem cell transplantation,” Nature. DOI: 10.1038/s41591-023-02587-y

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    Michigan Medicine – University of Michigan

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  • Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

    Pfizer gets FDA green light for new shot that can streamline teenagers’ vaccinations

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    Pfizer Inc.
    PFE,
    -1.73%
    said Friday that the U.S. Food and Drug Administration has approved the first five-in-one vaccine designed to protect teenagers and young adults against meningococcal disease. 

    The new Pfizer shot, Penbraya, protects against the five most common subgroups of meningococcal disease, a rare but serious and potentially fatal illness that most often affects babies and teenagers. 

    Penbraya “has the potential to protect more adolescents and young adults from this severe and unpredictable disease by providing the broadest meningococcal coverage in the fewest shots,” Annaliesa Anderson, Pfizer senior vice president and head of vaccine research and development, said in a statement. 

    The U.S. Centers for Disease Control and Prevention currently recommends that all 11- to 12-year-olds get a meningococcal vaccine protecting against four of the subgroups — A, C, W and Y — and get a booster dose of the same vaccine type at age 16. Teenagers and young adults age 16 to 23 may also get a meningococcal B vaccine, the CDC says, particularly if they’re at increased risk due to other health conditions. 

    The complex vaccination schedule has weighed on uptake of the meningococcal shots, and the COVID-19 pandemic may have compounded the problem, as many families missed routine appointments when vaccinations were due, researchers say. Among teenagers who were born in 2008 — who were due for their routine adolescent vaccinations as the pandemic was raging in 2020 — uptake of meningococcal and other recommended vaccines declined, according to CDC research. Only about 60% of the 17-year-olds surveyed by the CDC last year had received both recommended doses of the ACWY vaccine, and fewer than 30% had received at least one dose of the meningococcal B vaccine. 

    The new Pfizer shot combines components of a meningococcal group B vaccine and an ACWY vaccine. 

    A CDC immunization advisory committee is set to meet Oct. 25 to discuss recommendations for the use of Penbraya in teenagers and young adults, Pfizer said. 

    The green light for Penbraya gives Pfizer the edge in its race with GSK
    GSK,
    +0.54%    ,
    which is also working on a five-in-one meningococcal shot. GSK earlier this year released positive late-stage clinical-trial results for that vaccine. 

    The FDA approval of Pfizer’s shot caps a rocky week for the pharmaceutical giant, which late last Friday cut $9 billion from its full-year revenue guidance due to reduced COVID sales expectations and announced a cost-cutting program designed to deliver savings of at least $3.5 billion. Pfizer executives said on a call with analysts Monday that development of combination respiratory vaccines, such as those that provide COVID and flu protection in one shot, remains a focus for the company, in part because they can help boost vaccine uptake.

    Pfizer shares were down 1.7% Friday and have dropped 40% in the year to date, while the S&P 500
    SPX
    has gained 10%.

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  • Researchers aim to streamline brain surgery with a new soft robotic system

    Researchers aim to streamline brain surgery with a new soft robotic system

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    Newswise — Navigating the labyrinthine vasculature of the brain with standard surgical instruments can be incredibly challenging, even for the steadiest of hands. But with some robotic assistance, brain surgeons could potentially operate with far greater ease.

    Researchers at Johns Hopkins University and the University of Maryland have laid the groundwork for a soft robotic tool and control system that could grant surgeons an unprecedented degree of maneuverability within the brain. A recent study published in the International Journal of Computer Assisted Radiology and Surgery demonstrates that the new system is both intuitive and highly accurate. The early results suggest that, with further development, the robot could one day speed up and improve the efficacy of minimally invasive surgeries for life-threatening brain aneurysms and other serious conditions.

    One of the common approaches for treating a brain aneurysm — a weakened blood vessel that bulges and fills with blood — involves threading a plastic tube called a catheter through an artery, typically in the groin, with the goal of reaching and sealing off the aneurysm without causing any perforations along the way.

    To address the twists and turns of the vasculature, physicians can bend the tips of the catheters in a desired direction before inserting them. Then using their hands, they rotate the catheter as needed while pushing it toward the aneurysm. But this approach comes with a significant drawback.

    “With normal catheters, you can’t bend the tip in a different direction on demand once it’s inserted which causes trouble if an aneurysm is hard to reach,” said study co-author Ryan Sochol, Ph.D., a professor of mechanical engineering at the University of Maryland. “This particular problem appears to be quite consistent among neurosurgeons and others that perform endovascular interventions.”

    After hearing from neurosurgeons and studying surgical procedures, the authors of the new study concluded that a steerable robotic tool could greatly improve the process.

    The researchers designed an air pressure operated — or pneumatic — catheter tip which they 3D printed using a soft and flexible resin. The design includes two hollow channels running in parallel along the length of the tip, which, if pressurized individually, causes the tip to deflect to either the left or the right.

    While the catheter tip itself was inspired by existing designs, the authors sought to address a need that those previous robotic systems had not yet tackled — a control system that would fit well into the current clinical workflow.

    To provide physicians with a similar but improved method, the team developed a hand dial that allows for precise adjustments of the tip’s position, providing more control than rotating a pre-bent tip. Additionally, the dial offers haptic feedback that indicates when the tip is bent. With this system, the researchers grant the ability to simultaneously move a catheter forward with one hand while adjusting the angle of the tip with the other.

    To assess the device’s performance, the authors had two users — a skilled neurosurgeon and another with no prior surgical training — adjust the robotic tip’s position to hit an array of five 2-millimeter-wide cylindrical targets spaced less than 2 millimeters apart.

    Through 80 trials each, the users drove the catheters toward the cylinders with one hand and operated the dial with their other, bending the tips even closer to each target.

    The authors tracked how far off the tips were from the targets and the time it took the users to accomplish the tasks. The surgeon was clearly faster and more accurate, however, after several trials, the novice began closing the gap, almost matching their counterpart’s accuracy.

    “Both users were able to use the robotic system for sub-millimeter precision control, which is smaller than the two-millimeter diameter of brain vessels and the openings of aneurysms in the brain,” said senior author Axel Kreiger, Ph.D., a professor of mechanical engineering at Johns Hopkins University. “Overall, it was really nice to see that the results support the feasibility of the system.”

    With the study putting more wind in their sails, the authors are eager to continue developing the robotic tool with plans to shrink it to a more clinically relevant size and test it against targets in more anatomically accurate environments, Krieger explained.

    In the future, the authors also intend to increase their design’s functionality by adding tips in series, which could allow the device to bend into more complicated shapes and navigate difficult vascular environments.

    “The soft microcatheter tip is highly innovative and could be key for widespread use of robotics in endovascular surgery,” said Moria Bittmann, Ph.D., director of the NIBIB Robotics Program.

    This research was funded by a grant from NIBIB (R01EB033354), the Maryland Robotics Center and the Center for Engineering Concepts Development at the University of Maryland.

    This Science Highlight describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process — each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research.

    Study reference: Noah Barnes et al. Toward a novel soft robotic system for minimally invasive interventions. International Journal of Computer Assisted Radiology and Surgery (2023). DOI: 10.1007/s11548-023-02997-w

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    National Institute of Biomedical Imaging and Bioengineering

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  • Felix Beuschlein announced as winner of 2024 Transatlantic Alliance Award in Endocrinology

    Felix Beuschlein announced as winner of 2024 Transatlantic Alliance Award in Endocrinology

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    Newswise — The Endocrine Society and the European Society of Endocrinology (ESE) are delighted to announce that they have awarded the 2024 Transatlantic Alliance Award to Professor Felix Beuschlein, MD.

    Felix Beuschlein is Professor of Internal Medicine/Endocrinology and Director of the Clinic for Endocrinology, Diabetology and Clinical Nutrition at the University Clinic Zurich in Switzerland. He received his medical degree from School of Medicine at the University of Würzburg and completed his medical training in Freiburg, both in Germany. For postdoctoral studies he joined the University of Michigan in Ann Arbor. Following a professorship for Endocrine Research at the University of Munich, he was elected for a chair position at the University of Zurich in 2017. 

    The Transatlantic Alliance Award, which was launched in 2021, recognizes an international leader who has made significant advancements in endocrine research on both sides of the Atlantic—in Europe and the United States.

    Professor Beuschlein has received this prestigious Award in recognition of his transformational endocrine research and the impact of this research in the field of adrenal tumors. Through his collaborative approach across the European Network for the Study of Adrenal Tumors (ENS@T) with colleagues from the American Australasian Asian Adrenal Alliance (A5), he has fostered the transformation of knowledge and understanding of adrenal tumours and unlocked true transatlantic collaboration.

    “Felix Beuschlein has been instrumental in driving research forward in the adrenal tumor field and he has demonstrated what can be achieved when collaborating with colleagues across Europe and across the Atlantic,” said ESE President Professor Jérôme Bertherat. He added, “We are delighted to recognize his sizable contribution to endocrinology and the many committees he has been involved with.”

    “This Award honors Felix Beuschlein’s excellence in leadership, his lifetime achievement in teaching and research, and his outstanding contributions to the field of endocrinology,” said Endocrine Society President Stephen Hammes, MD, PhD. “In addition to his dedication to advancing adrenal tumor research, Dr. Beuschlein has paved the way for international exchange between fellow endocrine researchers and clinicians, both as the chair of our annual meeting in 2021, and as an associate editor of our flagship clinical research journal The Journal of Clinical Endocrinology & Metabolism. He is truly a worthy recipient of this award.”  

    Beuschlein’s scientific interests mainly relate to adrenal disorders and endocrine tumors. He has authored more than 460 publications in high-ranking international journals and has received many awards, including the European Journal of Endocrinology Prize and the Society for Endocrinology (UK) European Medal. He has organized several scientific meetings and has co-chaired the program organizing committee for a European Congress of Endocrinology (ECE) meeting and served as head of the annual meeting steering committee of the ENDO 2021 meeting. As a strong believer in the value of scientific and clinical networking, Beuschlein has been involved in numerous national and international approaches, including coordination of the ENS@T-CANCER Consortium and participation in a number of European and international programs. He has served on several boards including the Annual Meeting Steering Committee of the Endocrine Society, the Executive Committee of the Swiss Endocrine Society and has been the vice president of the German Endocrine Society. He has been a founding member, Steering Committee member and chairman of ENS@T.

    Beuschlein commented, “I am deeply moved to be this year’s recipient of the Transatlantic Alliance Award. As a strong believer in the power of international collaborations, this award comes as a particular honor as it signifies the connection of the international endocrine community through science and clinical care. The award reflects also more than personal achievement but rather a broad array of dedicated individuals – mentors who have guided me, colleagues with whom I share the dedication in endocrine research, and the next generation of students and researchers who bring fresh perspectives and renewed energy. I am obliged to both societies and applaud their common spirit to pushing the frontiers of endocrinology for the betterment of patient care worldwide.”

    Beuschlein will present his award lecture at ECE, the 26th European Congress of Endocrinology, which will take place from May 11-14, 2024, in Stockholm, Sweden. He will also speak at the Endocrine Society’s annual meeting, ENDO 2024, which will take place from June 1-4, 2024, in Boston, Mass.

    Nominations for the 2025 Transatlantic Alliance Award will open later this year.

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    About the Endocrine Society

    Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

    The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.

    About the European Society of Endocrinology

    The European Society of Endocrinology (ESE) provides a platform to develop and share leading research and best knowledge in endocrine science and medicine. By uniting and representing every part of the endocrine community, we are best placed to improve the lives of patients. With over 5,000 individual members and through the 51 National Societies involved with the ESE Council of Affiliated Societies (ECAS) ESE represents a community of over 20,000 European endocrinologists. We inform policy makers on health decisions at the highest level through advocacy efforts across Europe.

    To find out more, please visit www.ese-hormones.org. Follow us on Twitter @ESEndocrinology, Facebook @EuropeanSocietyofEndocrinology and LinkedIn: linkedin.com/company/european-society-of-endocrinology.

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    Endocrine Society

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  • Regular checkups may prevent kidney disease

    Regular checkups may prevent kidney disease

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    Newswise — Niigata, Japan – A new Japanese ecological study revealed that prefecture-specific participation rates for Specific Health Checkups (SHC participation rates) had significant negative effects on prefecture-specific standardized incidence rates (SIRs) of treated ESKD and prefecture-specific prevalence of chronic kidney disease (CKD). The findings support the importance of increasing SHC participation rates at the population level and encouraging people to undergo regular health checkups.

    “Japan has one of the highest incidence and prevalence rates of treated ESKD and substantial regional variation in the incidence of treated ESKD despite a uniform health care and insurance system and low ethnic and racial diversity,” said Dr. Wakasugi, the corresponding author of the study. “Large variations have been observed by prefecture in participation rates for SHC, an annual health screening program introduced by Japan’s Ministry of Health, Labour and Welfare since 2008 to identify individuals requiring specific health guidance to reduce the number of people having or at risk for, metabolic syndrome.”

    Using five sources of nationwide open data, the study revealed that SHC participation rates had significant direct negative effects on prefecture-specific SIRs and the prefecture-specific prevalence of CKD. Furthermore, through SHC participation rates, the ratio of nephrology specialists had a significant indirect negative effect on prefecture-specific SIRs, suggesting that a higher prefecture-specific ratio of nephrology specialists was associated with lower prefecture-specific SIRs. The structural equation modeling model explained 14% of the variance in prefecture-specific SIRs, indicating that prefecture-specific SHC participation rates can partially explain regional variation in prefecture-specific SIRs of treated ESKD.

    “Our findings concord with the Neyagawa Health Checkups and Health Care in Kokuho Database study, which showed that men who did not attend health checkups and did not undergo a kidney test using dipstick urinalysis and/or serum creatinine measurement at medical facilities were at significantly higher risk of treated ESKD than those who attended checkups, especially among those aged ≥75 years,” said Dr. Wakasugi. “Our findings provide evidence to support the importance of increasing SHC participation rates from a population-level perspective and encouraging people to undergo health checkups.”

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  • Tobacco sales up after e-cigarette restrictions

    Tobacco sales up after e-cigarette restrictions

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    Newswise — New Haven, Conn. — The immense popularity of electronic cigarettes, or e-cigarettes, among young people has led many policymakers to restrict the sale of flavored varieties. But rather than nudging people away from “vapes,” as these e-cigarettes are called, such measures could backfire by driving users to instead buy conventional cigarettes, a much more dangerous product, according to researchers at the Yale School of Public Health (YSPH).

    In a large-scale, long-term analysis of policies and sales data, the researchers found that for every 0.7 milliliters of “e-liquid” (the consumable content inside e-cigarettes, also known as vape juice) that goes unsold due to flavor restrictions, 15 additional traditional cigarettes are sold. The substitution was especially evident among cigarette brands popular with young people aged 20 and under, suggesting that flavor restrictions may increase smoking among youth as well as adults.

    The results suggest that this type of policy, which is intended to curb nicotine-related harms, may instead magnify them.

    “While neither smoking nor vaping is entirely safe, current evidence indicates substantively greater health harm from smoking than vaping nicotine products,” said first author Abigail S. Friedman, an associate professor in the YSPH Department of Health Policy & Management. “These policies’ public health costs may outweigh their benefits.”

    The study appears online as a pre-print prior to peer review at Social Science Research Network.

    Tempting flavors
    While randomized clinical trials show that e-cigarettes can be effective tools for quitting smoking, their availability in a wide range of flavors such as strawberry banana, breakfast cereal, lemonade, bubblegum, and cheesecake can make them especially tempting to youth.

    A 2019 outbreak of vaping-associated lung injuries led to thousands of hospitalizations and at least 68 deaths. While the outbreak’s primary cause was eventually identified as an additive most common in cannabis vaping products, its initial attribution to e-cigarettes — as well as worries that nicotine e-cigarettes may be an on-ramp to youth tobacco use — led hundreds of localities in the U.S. to restrict the sale of flavored vapes.

    Previous studies of such policies have mostly examined local or temporary post-2019 state policies. The Yale study was the first to assess how flavor restrictions across most of the United States influence sales of both vapes and cigarettes.

    Laws and consequences
    The authors used rigorous statistical tools to estimate long-term effects of e-cigarette flavor restrictions on electronic and conventional cigarette sales in jurisdictions across 16 states. They also examined how these effects varied between brands disproportionately used by underage youth versus adults.

    The authors first created a comprehensive database of tobacco product flavor prohibition and restriction laws across the United States, including both state and local statutes. They reviewed each policy to identify which tobacco products were covered —including vapes, cigars, and conventional cigarettes — which flavors were restricted, when the policies would take effect, and any exemptions for certain types of businesses, such as adult-only tobacco stores.

    They compared this information against vape and cigarette sales data over four-week intervals from January 2018 through March 2023, a period during which flavor restrictions went from affecting 1.3% of the U.S. population to affecting 38%. The sales data came from ordinary brick-and-mortar establishments like gas stations, groceries, and convenience stores. Statistical analyses took into account a host of other factors that may affect tobacco product sales, such as concurrent restrictions on flavored cigar and menthol cigarette sales, tax rates, cannabis availability, and unemployment rates.

    The primary outcome of interest was volume sales of conventional cigarettes and e-cigarettes per capita, during each four-week period, both overall and by type of flavor. Cigarette volumes are measured in packs, while e-cigarettes are standardized to 0.7-milliliter units, given past industry claims that one 0.7-milliliter vape pod is equivalent to 20 conventional cigarettes, or one pack.

    These methods had limitations. Sales data did not include e-cigarette sales made online, in vape shops, or via illicit markets. However, the data did capture most sales of conventional cigarettes. While the study was not a randomized experiment, the analytical methods used were robust enough to identify causal relationships.

    Swapping cigarettes for vapes
    During the study period, hundreds of localities and seven states restricted or prohibited flavored e-cigarette sales. While these policies did reduce per-capita vape sales, they also substantially boosted cigarette sales.

    For each 0.7 milliliters of e-cigarette e-liquid not sold due to these policies, the authors calculated that 15 additional cigarettes were purchased. Similar results emerged when they excluded individual states with statewide policies from the analysis, showing that no one state was driving this effect. Bans on all vapes, including both flavored and unflavored, also resulted in more cigarette sales.

    Of the increase in cigarette sales, 71% were of non-menthol cigarettes, suggesting that restrictions on menthol cigarettes would not counteract this effect.

    Where e-cigarette flavor restrictions had been in effect for at least a year, sales of cigarette brands favored by adults went up by 10%, while sales of cigarette brands that disproportionately attract underage smokers saw a 20% bump.

    In light of these results, policymakers might want to consider other approaches to protect public health where tobacco is concerned, the authors wrote in the study.

    “Some leading scholars have advocated for regulating tobacco products proportionate to their risk,” they wrote. “This approach would avoid giving more lethal combustible products [such as cigarettes] a competitive advantage over less lethal alternatives…[and] could mean more flavors being available in [vapes] than cigarettes.”

    The authors report that they have no conflicts of interest. The research was funded by National Institutes of Health awards from the National Cancer Institute and Food and Drug Administration, as well as the National Institute on Drug Abuse.

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  • Mental health challenges for Canadian ulcer patients in COVID-19 pandemic

    Mental health challenges for Canadian ulcer patients in COVID-19 pandemic

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    Newswise — Toronto, ON — New research from the University of Toronto has revealed the mental health toll of the COVID-19 pandemic on older adults with peptic ulcer disease (PUD), a painful condition in which gastric sores develop in the lining of the stomach or upper portion of the small intestine.

    The researchers examined a subsample of older adults from the Canadian Longitudinal Study on Aging, a national dataset of older Canadians. The sample consisted of 1,140 older adults with PUD, of whom 689 had a pre-pandemic history of depression and 451 had no history of depression. By using longitudinal data, the researchers were able to compare the mental health trajectories of those with and without a history of depression.  The article was published this week in PLOS ONE.

    Among older adults with PUD and no lifetime history of depression, approximately 1 in 8 (13.0%) developed depression for the first time during the COVID-19 pandemic. These numbers were substantially higher when compared to depression levels before the pandemic (2015-2018).

    “Although individuals with peptic ulcers were already known to be vulnerable to depression, our findings show that the pandemic severely exacerbated this vulnerability,” said lead author Esme Fuller-Thomson, Professor at the University of Toronto’s Factor-Inwentash Faculty of Social Work (FIFSW) and director of the Institute for Life Course & Aging (ILCA). “COVID-19 introduced many unforeseen stressors for people with chronic health conditions, such as higher levels of stress and lower levels of physical activity and social support, which may contribute to their worsening mental health.”

    When the analysis was limited to those who had a lifetime history of depression, approximately 1 in 2 (46.6%) experienced recurrent or persistent depression during the pandemic.

    “One of the major risk factors for depression in later life is having a previous history of depressive episodes,” said co-author Hannah Dolhai, a former research assistant at the ILCA. “Older adults with a history of depression who also had to navigate challenges with managing their chronic illness during the pandemic are a vulnerable subpopulation of Canadians.”

    The researchers also identified several risk factors for depression among those with PUD, such as experiencing difficulty accessing healthcare.

    “We found that individuals who reported challenges with healthcare access during the pandemic had a higher risk for depression. It’s important to think about the potential cascading mental health consequences of the healthcare restrictions that occurred during COVID-19,” said co-author Andie MacNeil, a research assistant at the FIFSW and Institute for Life Course and Aging. “While the shift towards telemedicine helped maintain healthcare continuity for many individuals, it is not always accessible or preferable for some patients”

    Other risk factors for depression among older adults with PUD included feeling lonely at the beginning of the pandemic and experiencing functional limitations.

    “Loneliness is a well-established risk factor for depression. For many older adults, the physical distancing limitations early in the pandemic meant increased time alone and declines in social support. Although these guidelines were important to protect the health of Canadians, they can also had unintended mental health consequences. It is important to find ways to foster social connection even when staying apart,” said co-author Grace Li, PhD candidate in the Sociology Department at the University of Victoria.

    Co-author Ying Jiang, Senior Epidemiologist at the Public Health Agency of Canada points out that previous research on the relationship between PUD and depression has highlighted how symptoms like chronic pain can severely disrupt functional status and dramatically reduce quality of life in patients. “It is unsurprising that this relationship persisted into the pandemic, and that those with reduced functional status faced a higher risk of depression,” Jiang said.

    Women were also found to have a higher risk of depression when compared to men.

    “During the pandemic, many women experienced increased household labour and caregiving responsibilities due to school closures and restrictions in other community services, like older adult day programs. This exacerbation of gender-role stress may have impacted the mental health of many women,” said co-author Margaret de Groh, Scientific Manager at the Public Health Agency of Canada.

    “By drawing attention to those with the highest risk for depression, we hope our findings will help inform targeted screening and intervention. Many older adults may still need mental health support in the post-COVID era,” said Fuller-Thomson.

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  • Study Unveils Promising Pancreatic Cancer Treatment Approach.

    Study Unveils Promising Pancreatic Cancer Treatment Approach.

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    Newswise — A new study carried out in mice, led by Queen Mary University of London, has identified cells that drive the spread of pancreatic cancer and discovered a weakness in these cells that could be targeted using existing drugs. This offers a promising new approach for treating pancreatic cancer.

    The research, published in Science Advances and funded by Barts Charity and Cancer Research UK, found that many patients’ pancreatic cancer contains cells called amoeboid cells. These are aggressive, invasive and fast-moving cells that weaken the immune system. These cells have previously been identified in other cancers, such as melanoma, breast, liver and prostate cancer, and have been linked with poor survival rates. This is the first time that they have been found in pancreatic cancer.

    Crucially, the new study discovered amoeboid cells in pancreatic cancer produce high levels of a molecule called CD73, which drives their ability to spread and weaken the immune system. When blocking this molecule, the researchers reduced the spread of cancer to the liver and decreased the number of immune cells that supported the tumour.

    The research looked at mice given anti-CD73 treatment over the short term (3 weeks) and long term where clinical endpoints were met (when an outcome that represents direct clinical benefit was achieved, such as survival, decreased pain, or the absence of disease). In the long-term group, anti-CD73 treatment reduced the incidence of cancerous tumours that spread to the liver from 66.6 per cent to 36.4 per cent.

    While further tests would be needed involving humans to confirm the conclusions, the study suggests that blocking CD73 could be a promising approach for treating pancreatic cancer and the spread of it, especially considering that drugs blocking CD73 have already been developed and are being tested in clinical trials for various types of cancer.

    The amoeboid cells were present in both late and early-stage pancreatic cancer. This opens up a new possible avenue of treatment in blocking CD73 early in the disease and reducing the aggressive nature of these cells and the damage they cause in the body.

    Professor Victoria Sanz-Moreno, Professor of Cancer Cell Biology at Queen Mary University of London, said:

    “While the results would need to be replicated in humans, they are very promising in highlighting a potential way of treating the spread of one of the most aggressive and poorly survived cancers.

    “More than 10,000 people are diagnosed with pancreatic cancer in the UK every year, so finding a way to improve its extremely low survival rate even by a little could save many years of human life.

    “Pancreatic cancer remains one of the deadliest cancers and current treatments are not working well. To improve these, we urgently need to understand the disease better.”

    Victoria King, Director of Funding and Impact at Barts Charity said:

    “The ability of cancer cells to spread to other parts of the body is one of the greatest clinical challenges to treating cancer. Our investment in cancer research at Queen Mary has helped to attract world-leading researchers to East London who are making scientific breakthroughs that could transform the lives of people with cancer. We are excited to see the insights presented in this study, which suggest a promising new approach for halting the spread of pancreatic cancer.”

    Dr Claire Bromley, Senior Research Information Manager at Cancer Research UK, said: 

    “Thanks to research, over one million lives have been saved from cancer since the 1980s, but improvements haven’t been equal across all cancer types. Pancreatic cancer remains hard to treat and survival hasn’t improved in the past 50 years.

    “Research like this is vital to innovate new ways to treat pancreatic cancer, which is the fifth most common cause of cancer in the UK. The team’s discoveries offer a promising new route for drugs of the future. However, more research is needed before these findings can move from the laboratory bench to the bedside.” 

    Despite advances made in early diagnosis and treatment, the survival rate of pancreatic cancer remains extremely low. Only around 7 per cent of people survive five years after their diagnosis, and current therapies, which may include surgery, chemotherapy, or radiotherapy, do not work well for most patients.

    Like all cancers, early diagnosis is key to improving survival rates. For pancreatic cancer, around half of all patients are diagnosed when the disease has already spread, which is one of the reasons for poor survival rates.

    The researchers plan to expand their research to other cancers and see if they uncover the same link between amoeboid cells and CD73. A key focus will be breast cancer, which is the most common type of cancer in the UK and the second most common cause of cancer death in women.

    The research funders include Barts Charity, Cancer Research UK and the National Institute for Health and Care Research (NIHR) Biomedical Research Centre based at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. No NIHR BRC funds were used for animal studies.

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  • Brain Immune Cell to Neuron Conversion Aids Post-Stroke Mouse Recovery.

    Brain Immune Cell to Neuron Conversion Aids Post-Stroke Mouse Recovery.

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    Newswise — Fukuoka, Japan – Researchers at Kyushu University have discovered that turning brain immune cells into neurons successfully restores brain function after stroke-like injury in mice. These findings, published on October 10 in PNAS, suggest that replenishing neurons from immune cells could be a promising avenue for treating stroke in humans.

    Stroke, and other cerebrovascular diseases, occur when blood flow to the brain is affected, causing damage to neurons. Recovery is often poor, with patients suffering from severe physical disabilities and cognitive problems. Worldwide, it’s one of the most common causes for needing long-term care.

    “When we get a cut or break a bone, our skin and bone cells can replicate to heal our body. But the neurons in our brain cannot easily regenerate, so the damage is often permanent,” says Professor Kinichi Nakashima, from Kyushu University’s Graduate School of Medical Sciences. “We therefore need to find new ways to replace lost neurons.”

    One possible strategy is to convert other cells in the brain into neurons. Here, the researchers focused on microglia, the main immune cells in the central nervous system. Microglia are tasked with removing damaged or dead cells in the brain, so after a stroke, they move towards the site of injury and replicate quickly.

    “Microglia are abundant and exactly in the place we need them, so they are an ideal target for conversion,” says first author, Dr. Takashi Irie from Kyushu University Hospital.

    In prior research, the team demonstrated that they could induce microglia to develop into neurons in the brains of healthy mice. Now, Dr. Irie and Professor Nakashima, along with Lecturer Taito Matsuda and Professor Noriko Isobe from Kyushu University Graduate School of Medical Sciences, showed that this strategy of replacing neurons also works in injured brains and contributes to brain recovery.

    To conduct the study, the researchers caused a stroke-like injury in mice by temporarily blocking the right middle cerebral artery – a major blood vessel in the brain that is commonly associated with stroke in humans. A week later, the researchers examined the mice and found that they had difficulties in motor function and had a marked loss of neurons in a brain region known as the striatum. This part of the brain is involved in decision making, action planning and motor coordination.

    The researchers then used a lentivirus to insert DNA into microglial cells at the site of the injury. The DNA held instructions for producing NeuroD1, a protein that induces neuronal conversion. Over the subsequent weeks, the infected cells began developing into neurons and the areas of the brain with neuron loss decreased. By eight weeks, the new induced neurons had successfully integrated into the brain’s circuits.

    At only three weeks post-infection, the mice showed improved motor function in behavioral tests. These improvements were lost when the researchers removed the new induced neurons, providing strong evidence that the newly converted neurons directly contributed to recovery.

    “These results are very promising. The next step is to test whether NeuroD1 is also effective at converting human microglia into neurons and confirm that our method of inserting genes into the microglial cells is safe,” says Professor Nakashima.

    Furthermore, the treatment was conducted in mice in the acute phase after stroke, when microglia were migrating to and replicating at the site of injury. Therefore, the researchers also plan to see if recovery is also possible in mice at a later, chronic phase.

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  • Waymark Secures Additional $42M to Scale Tech-Enabled, Community-Based Care for Primary Care Providers and People Enrolled in Medicaid

    Waymark Secures Additional $42M to Scale Tech-Enabled, Community-Based Care for Primary Care Providers and People Enrolled in Medicaid

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    New Funding Will Support Waymark’s Market Expansion and Technology Investments to Continue Improving Access and Outcomes for Medicaid Recipients


    SAN FRANCISCO, October 18, 2023 (Newswire.com)
    –
    Waymark, the Medicaid provider enablement company, today announced $42 million in new financing to scale technology-enabled, community-based care for primary care providers and their patients enrolled in Medicaid programs. Existing investor Lux Capital led the oversubscribed round, and CVS Health Ventures, the venture capital arm of CVS Health, joins the company as a new investor. Existing investors Andreessen Horowitz (a16z) and New Enterprise Associates (NEA) also participated in the round. The investment consists of $22 million in equity capital and a $20 million line of credit, bringing Waymark’s total capital raised to date to $87 million. 

    “CVS Health Ventures’ investment portfolio is comprised of innovative companies that are at the forefront of transforming care delivery. Waymark’s use of proprietary data science technologies to improve access and quality of care is doing exactly that,” said Vijay Patel, Managing Partner and co-founder, CVS Health Ventures. “We expect this investment will provide Medicaid members expanded access to coordinated and holistic health care.”

    Waymark will use its new investment to continue improving healthcare access and outcomes for people enrolled in Medicaid programs. Patients receiving Medicaid benefits often experience challenges accessing care, prescriptions, and social support like housing and food. Waymark hires, trains, and deploys local teams of community health workers, pharmacists, therapists and care coordinators to work directly with primary care practices — at no cost to the practice — and address gaps in care for their patients enrolled in Medicaid. The company’s local teams are supported by Waymark Signal™, a proprietary machine learning technology that has shown industry-leading performance in identifying “rising risk” populations, or patients at risk of avoidable emergency room (ER) and hospital utilization, and helps to direct Waymark teams to the best evidence-based intervention to meet patient goals. The technology is integrated into a care management software built by Waymark specifically for community-based teams, and incorporates data from multiple sources (e.g., local ERs, primary care practices, social services databases, and health plan data) to engage patients who are traditionally hard to reach. 

    “Medicaid programs have historically been overlooked and under-innovated, but Waymark’s groundbreaking partnerships demonstrate the positive impact technology-enabled services can have for communities who need it most,” said Deena Shakir, General Partner at Lux Capital. “By aligning business incentives with patient outcomes, Waymark continues to build a uniquely effective approach to advance population health. There is no better team or technology out there to take this challenge on, and we are thrilled to deepen our partnership with the entire Waymark team.”

    Waymark is currently supporting approximately 50,000 people enrolled in Medicaid across both Washington state and Virginia. Since launching in January 2023, the company has secured partnerships with several large health systems, a federally qualified health center (FQHC), and independent practices across both markets. Through its evidence-based care pathways, Waymark has shown promising early improvements in quality scores and clinical outcomes — including reduced non-emergent emergency department (ED) visits and hospitalizations.

    Providence, one of the largest health systems in the country, is working with Waymark to improve access to care for patients receiving Medicaid. “At Providence, we’re committed to addressing inequities in the communities we care for,” said Dr. Scott Anders, CMO, Value Based Care, Providence Clinical Network, Providence Health & Services. “Waymark provides a disciplined Medicaid population health management approach that improves access to high-value care. Waymark’s use of data science combined with a local, person-centered process is compelling, and we are eager to see how they proactively help patients access the care they need.” 

    At community clinics like Country Doctor Community Health Center (CDCHC), a Seattle-based federally qualified health center (FQHC) with roots in the civil rights movement, Waymark is helping to increase provider capacity and deliver whole-person care to patients. “We chose to partner with Waymark because their local, community-based, multidisciplinary care model aligns not only with the evidence of what works in Medicaid, but also our own mission and values,” said Matthew Logalbo, MD and Medical Director, CDCHC. “We have worked hard to develop services tailored to the needs of our patients (e.g., our low-barrier addiction treatment clinic, peer support specialists, re-entry CHWs, and healthcare for the homeless services), but we can’t meet the level of demand that exists alone. Waymark provides us with more capacity outside the clinic setting to engage and support patients, bring them into care, and connect them to our programs and other resources in the community that can address patients’ social determinants of health.”

    Waymark enters into risk-based contracts with Medicaid MCOs to deliver community-based care for their rising risk populations and transition primary care practices to value-based arrangements. By building a new community health workforce to support primary care providers (PCPs) — paid for through value-based arrangements with MCOs — Waymark seeks to increase the capacity of its healthcare delivery system and align payment incentives to enable whole-person care.

    “We created Waymark because the evidence of what works to improve Medicaid outcomes exists, but the operational capacity, technology and funding is insufficient to scale to the level of need that exists in communities across the country,” said Dr. Rajaie Batniji, co-founder and CEO of Waymark. “This new financing will allow us to continue hiring and training a new community health workforce, expand PCP capacity, and ultimately deliver on our charter to improve access and quality of care for people receiving Medicaid.” 

    Source: Waymark

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  • Ardelyx wins long battle for FDA approval of kidney-disease treatment 

    Ardelyx wins long battle for FDA approval of kidney-disease treatment 

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    Ardelyx Inc.
    ARDX,
    -0.58%
    on Tuesday won its long fight for U.S. regulatory approval of a treatment designed to help patients with chronic kidney disease.

    The biopharma company said late Tuesday that the U.S. Food and Drug Administration approved tenapanor, marketed under the brand name Xphozah, for control of serum phosphorus in patients with chronic kidney disease on dialysis. A high level of phosphorus in the blood is often a sign of kidney damage and can lead to weak bones, joint pain, cardiovascular problems and other issues.    

    The approval concludes an extraordinary comeback for Xphozah. Ardelyx’s application for approval of the treatment was previously rejected by the FDA in July 2021, when the agency said the drug’s effect was “small and of unclear clinical significance.” To preserve cash, Ardelyx a few months later said it would cut its workforce by 65%, but it also pursued multiple appeals of the agency’s decision. An FDA advisory committee voted last November that the benefits of Xphozah outweigh its risks. The agency late last year ultimately granted Ardelyx’s appeal, and the company resubmitted its Xphozah application to the FDA in April. 

    More than 550,000 people in the U.S. have chronic kidney disease and are on maintenance dialysis. The vast majority of them have high phosphorus levels, also called hyperphosphatemia, according to Ardelyx. 

    High phosphorus levels “must be taken care of in these patients, and the current therapies are mostly insufficient in doing so,” Ardelyx CEO Mike Raab told MarketWatch. 

    Chronic kidney disease patients with high phosphorus levels have traditionally been treated with phosphate binders that can soak up phosphorus from food during digestion, but that approach can require patients to swallow a large number of pills. The Xphozah treatment requires two pills a day, “each the size of a Tic Tac,” Raab said. 

    The FDA approved Xphozah as add-on therapy in patients who can’t tolerate or have an inadequate response to phosphate binders, Ardelyx said in a release.

    Xphozah, which will be Ardelyx’s second U.S. product launch, should be available sometime in November, Raab said.

    Ardelyx will present updated data on Xphozah for hyperphosphatemia at an American Society of Nephrology meeting in early November, the company said in a release Monday. 

    Ardelyx shares jumped in late September after Japanese regulators approved tenapanor for hyperphosphatemia in adults with chronic kidney disease on dialysis. 

    Ardelyx shares fell 0.6% on Tuesday and have gained 21% in the year to date, while the S&P 500
    SPX
    has gained 13.9%. 

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  • American College of Surgeons Releases Online Version of Disaster Management and Emergency Preparedness Course

    American College of Surgeons Releases Online Version of Disaster Management and Emergency Preparedness Course

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    Newswise — CHICAGO (October 17, 2023): In a world where unexpected emergencies and natural disasters are ever-present, preparedness is paramount. The American College of Surgeons (ACS) recently released the online version of its Disaster Management and Emergency Preparedness (eDMEP) course, making this important content accessible to a wider audience. 

    The eDMEP course provides physicians with essential knowledge and best practices for responding to mass casualty incidents. The course focuses on the hospital response to disaster. The overall goal is to motivate action and stimulate critical thinking to be ready for, respond to, and recover from disasters. Featuring diverse scenarios ranging from earthquakes to complex terrorist attacks, this comprehensive course ensures that learners are well-equipped to manage unforeseen emergencies. 

    What sets eDMEP apart is its innovative interactive approach. Each scenario immerses the learner into the crucial role of a trauma surgeon or triage officer responding to a specific disaster. The interactive scenarios help learners hone their triage skills in a virtual setting, preparing them for real-life situations. Furthermore, each scenario is tailored to the respective disaster, ensuring that casualties and injuries accurately reflect the conditions and unique needs of that event. 

    “Just like trauma, disaster management is a team endeavor. It requires ‘all hands-on deck,’ from the managers to the cleaning crews and from the trauma surgeons to the internists. This course not only provides information to all members of the disaster management team, it takes them by the hand and walks them through all the steps of disaster preparation, response, and recovery. The eDMEP case scenarios take online surgical education to the next level, providing opportunities to make decisions about patient care in realistic mass casualty situations by incorporating elements of game theory,” said Jeannette M. Capella, MD, MEd, FACS, Education Program Chair, ACS Disaster Management and Emergency Preparedness (DMEP)/eDMEP. 

    The first eDMEP scenario addresses earthquake preparedness. The ACS will be rolling out additional scenarios, with the complete collection slated for early 2024. 

    The eDMEP course is a collaborative effort between the ACS and a distinguished panel of surgeons and experts experienced in disaster management. The new online version builds upon the longstanding ACS DMEP course, an in-person trauma education initiative focused on preparing medical professionals for mass casualty incidents. Through engaging lectures and interactive scenarios, DMEP imparts valuable knowledge on incident command terminology, disaster triage principles, injury patterns, and the resources available for assistance. 

    The overarching objectives of the eDMEP course encompass: 

    • Preparing participants for disaster readiness, response, and recovery 
    • Empowering participants to contribute effectively to hospital disaster preparedness 
    • Training participants to practice hospital disaster plans using interactive scenarios 

    More information about both eDMEP and the in-person DMEP courses is available on the ACS website. Both options provide extensive training and equip participants to effectively tackle mass casualty incidents. 

    # # # 

    About the American College of Surgeons 

    The American College of Surgeons is a scientific and educational organization of surgeons that was founded in 1913 to raise the standards of surgical practice and improve the quality of care for all surgical patients. The College is dedicated to the ethical and competent practice of surgery. Its achievements have significantly influenced the course of scientific surgery in America and have established it as an important advocate for all surgical patients. The College has approximately 90,000 members and is the largest organization of surgeons in the world. “FACS” designates that a surgeon is a Fellow of the American College of Surgeons. 

     

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  • Can Lifestyle Interventions Benefit Patients With Advanced Breast Cancer?

    Can Lifestyle Interventions Benefit Patients With Advanced Breast Cancer?

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    Newswise — MIAMI, FLORIDA (Oct. 17, 2023) – Can lifestyle interventions such as exercise and intermittent fasting help patients with advanced breast cancer better tolerate side effects from treatment?

    That is the question Tracy Crane, PhD, RDN,  and Carmen Calfa, MD, at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and their collaborators will strive to answer with a $4-million, five-year grant from the National Cancer Institute (NCI).

    Crane, co-lead of Cancer Control and director of Lifestyle Medicine, Prevention and Digital Health at Sylvester, is multiple principal investigator, along with Christina Dieli-Conwright, PhD, and Jennifer Ligibel, MD, from Dana Farber Cancer Institute. Calfa, medical co-director of Cancer Survivorship and Translational Behavioral Sciences at Sylvester, is co-investigator for this phase II, randomized trial, which will include 260 women with advanced breast cancer. The trial is being conducted in English and Spanish and focuses on women starting a CDK4/6 inhibitor medication in combination with hormonal therapy. Researchers hypothesize that the prolonged overnight fasting with and without exercise during daylight hours will help with alignment of circadian activity rhythms and ultimately improve levels of fatigue. Circadian activity rhythms include sleep/wake cycles and physical activity and disruption of these significantly disturbs homeostasis of a variety of biological and metabolic processes including immune function, cellular aging and death.

    Crane said it will build on a recently completed pilot study among 30 women with advanced breast cancer demonstrating that prolonged overnight fasting, a type of intermittent fasting, and exercise interventions were well tolerated and led to reduced fatigue and improved quality of life.

    “We know from previous studies of patients with early breast cancer that lifestyle interventions can reduce fatigue, improve physical function and lessen the impact of other treatment-related side effects,” Crane said. “However, there are few studies and limited data about the impact of exercise and dietary interventions on patients living with advanced breast cancer.”

    About 300,000 new cases of invasive breast cancer are diagnosed every year and about 40,000 women die of metastatic disease, even though treatment for breast cancer has improved significantly in recent years.

    “Although patients are living longer than ever with advanced breast cancer, newer targeted therapies can cause significant side effects, including fatigue, decreased immune defense as well as gastrointestinal symptoms, Calfa explained. “Additionally, hormonal treatments used in combination with targeted therapies can result in menopausal symptoms, mood disorders and impaired sleep.”

    “For some patients,” she added, “the side effects can become debilitating, resulting in them discontinuing treatment and subsequently compromising their oncological outcome. Empowering women with lifestyle interventions that allow them to take charge and drive a positive outcome is essential and I m delighted to take part in this important project.”

    In this study, researchers will evaluate the effectiveness of supervised exercise and prolonged overnight fasting, alone or in combination, on fatigue, biomarkers of inflammation, sleep quality, physical function, body composition and patient-reported outcomes related to depression, anxiety and quality of life versus those in an attention-control supportive care group.

    Outcomes will be assessed 12 weeks after patients enroll in the trial and then again at six and 12 months.

    With October being Breast Cancer Awareness Month, Crane believes the trial’s timing is fortuitous for women living with advanced breast cancer.

    “Our research has the potential to improve treatment tolerability, quality of life and possibly life duration for women living with advanced breast cancer,” Crane said. “Those are the most meaningful outcomes for these women.”

    Enrollment in the study is anticipated to open in early 2024. For more information, check the Crane Lab website.

    Read more about this study on the InventUM blog.

    # # #

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    Sylvester Comprehensive Cancer Center

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  • Lonza Warns on 2024 Profitability Hit From Lost Moderna Revenue

    Lonza Warns on 2024 Profitability Hit From Lost Moderna Revenue

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    Updated Oct. 17, 2023 2:47 am ET

    Lonza Group warned that its profitability will take a hit next year from losing revenue from an agreement with Moderna and the risk of a smaller business with Kodiak Sciences.

    Copyright ©2023 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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  • Debt-ridden Rite Aid files for bankruptcy, will close more stores

    Debt-ridden Rite Aid files for bankruptcy, will close more stores

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    Drugstore chain Rite Aid Corp. filed for bankruptcy Sunday, as it faces billions of dollars of debt related to opioid lawsuits.

    In a statement Sunday night, Rite Aid
    RAD,
    -16.81%
    said it will close some “underperforming” stores and announced Jeffrey Stein as its new chief executive and chief restructuring officer. Interim CEO Elizabeth Burr will remain on the company’s board.

    The bankruptcy filing had been expected for months, and the Wall Street Journal reported in August that Rite Aid was more than $3.3 billion in debt, due largely to hundreds of lawsuits related to its distribution of opioid painkillers. The bankruptcy filing stays pending litigation against the company.

    Earlier this month, the New York Stock Exchange warned Rite Aid that it was “no longer in compliance” with the exchange’s minimum pricing and valuation standards, and gave it six months for the stock to regain compliance. Rite Aid shares have plunged about 80% year to date.

    Rite Aid said Sunday that lenders will provide $3.45 billion in financing for the chain to continue operating through the chapter 11 bankruptcy process.

    “With the support of our lenders, we look forward to strengthening our financial foundation, advancing our transformation initiatives and accelerating the execution of our turnaround strategy,” Stein said in a statement. “In doing so, we will be even better able to deliver the healthcare products and services our customers and their families rely on — now and into the future.”

    Rite Aid said it would work to minimize the effect of store closures on its customers so there is no disruption of services, and will transfer affected workers to different locations when possible.

    Rite Aid has about 2,100 stores and employs around 47,000 people. It has closed more than 200 stores in the past couple of years.

    Rite Aid also said it had reached a deal for pharmacy benefit-solutions company MedImpact Healthcare Systems Inc. to acquire its Elixer Solutions business. A price for the transaction was not disclosed.

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  • Debt-ridden Rite Aid files for bankruptcy, will close more stores

    Debt-ridden Rite Aid files for bankruptcy, will close more stores

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    Drugstore chain Rite Aid Corp. filed for bankruptcy Sunday, as it faces billions of dollars of debt related to opioid lawsuits.

    In a statement Sunday night, Rite Aid
    RAD,
    -16.81%
    said it will close some “underperforming” stores and announced Jeffrey Stein as its new chief executive and chief restructuring officer. Interim CEO Elizabeth Burr will remain on the company’s board.

    The bankruptcy filing had been expected for months, and the Wall Street Journal reported in August that Rite Aid was more than $3.3 billion in debt, due largely to hundreds of lawsuits related to its distribution of opioid painkillers. The bankruptcy filing stays pending litigation against the company.

    Earlier this month, the New York Stock Exchange warned Rite Aid that it was “no longer in compliance” with the exchange’s minimum pricing and valuation standards, and gave it six months for the stock to regain compliance. Rite Aid shares have plunged about 80% year to date.

    Rite Aid said Sunday that lenders will provide $3.45 billion in financing for the chain to continue operating through the chapter 11 bankruptcy process.

    “With the support of our lenders, we look forward to strengthening our financial foundation, advancing our transformation initiatives and accelerating the execution of our turnaround strategy,” Stein said in a statement. “In doing so, we will be even better able to deliver the healthcare products and services our customers and their families rely on — now and into the future.”

    Rite Aid said it would work to minimize the effect of store closures on its customers so there is no disruption of services, and will transfer affected workers to different locations when possible.

    Rite Aid has about 2,100 stores and employs around 47,000 people. It has closed more than 200 stores in the past couple of years.

    Rite Aid also said it had reached a deal for pharmacy benefit-solutions company MedImpact Healthcare Systems Inc. to acquire its Elixer Solutions business. A price for the transaction was not disclosed.

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  • MD Anderson Research Highlights: ESMO 2023 Special Edition

    MD Anderson Research Highlights: ESMO 2023 Special Edition

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    ABSTRACTS: LBA71, 1088MO, 95MO, LBA48, 1082O, 1085O, LBA34, 243MO

    Newswise — MADRID ― The University of Texas MD Anderson Cancer Center’s Research Highlights provides a glimpse into recent basic, translational and clinical cancer research from MD Anderson experts.

    This special edition features upcoming oral presentations by MD Anderson researchers at the 2023 European Society for Medical Oncology (ESMO) Congress focused on clinical advances across a variety of cancer types. Highlights include a combination strategy for EGFR-mutant metastatic lung cancer, updated results for a Phase II study on immunotherapy for skin cancer, a promising drug for bile duct cancer, pre-surgical treatment options for resectable melanoma, concurrent intrathecal and intravenous treatment for leptomeningeal disease, a triplet combination for melanoma brain metastases, promising results for an antibody drug conjugate targeting HER2, and the option to eliminate surgery for a subset of breast cancer patients. More information on ESMO content from MD Anderson can be found at MDAnderson.org/ESMO.

    In addition to the studies summarized below, forthcoming press releases will feature the following late-breaking and oral presentations:

    • Results from the Phase III CheckMate 77T study evaluating neoadjuvant nivolumab plus chemotherapy vs. neoadjuvant placebo plus chemotherapy followed by surgery and adjuvant nivolumab for untreated, resectable stage II-IIIB non-small cell lung cancer (Abstract LBA1)
    • Results from the Phase III DUO-E trial for newly diagnosed advanced or recurrent endometrial cancer (Abstract LBA41)
    • Results from the Phase III THOR study on erdafitinib vs. pembrolizumab in pretreated patients with advanced or metastatic urothelial cancer (Abstract 2359O)
    • Subgroups from the Phase III THOR study on erdafitinib vs. chemotherapy in patients with advanced or metastatic urothelial cancer with select FGFR alterations (Abstract 2362MO) 

    Combination treatment prolongs survival in patients with EGFR-mutant lung cancer (Abstract LBA71)  
    Osimertinib, an EGFR inhibitor, is the current standard first-line treatment for patients with metastatic EGFR-mutant non-small cell lung cancer (NSCLC), yet there is a need to identify improved treatments to enhance its initial efficacy. In the randomized Phase II RAMOSE trial, researchers led by Xiuning Le, M.D., Ph.D., found combining osimertintib with ramucirumab, an anti-VEGF treatment, significantly prolonged progression-free survival (PFS). The median PFS was 24.8 months in the combination arm compared to 15.6 months for those who received osimertintib alone. The combination also demonstrated a favorable safety profile. This study suggests osimertinib plus ramucirumab should be considered as a first-line treatment option for patients with EGFR-mutant metastatic NSCLC. Le will present the updated findings on October 21.

    Pre-surgical immunotherapy improves patient outcomes in advanced operable cutaneous squamous cell carcinoma (Abstract 1088MO) Patients with cutaneous squamous cell carcinoma (CSCC), the second most common form of skin cancer, typically present with early-stage disease that can be treated with surgery alone, though a subset with more advanced disease will require radiation in addition to surgery. In a one year follow-up to a multicenter Phase II study led by Neil D. Gross, M.D., neoadjuvant (pre-surgical) immunotherapy given to patients with advanced resectable CSCC demonstrated favorable survival outcomes with a median follow-up duration of 18.7 months. The study included 79 participants treated with neoadjuvant cemiplimab followed by curative-intent surgery. Based on treatment response, patients were offered up to 48 weeks of adjuvant cemiplimab, radiation therapy or observation only. Estimated 12-month event-free survival was 89%. Notably, none of the 40 patients with a pathological complete response (pCR) experienced recurrence. The results indicate that neoadjuvant cemiplimab followed by surgery is a viable treatment option for advanced, operable CSCC. A Phase III trial is planned to test this novel approach. Gross will present updated findings on Oct. 21.

    Tinengotinib delivers promising efficacy in patients with advanced cholangiocarcinoma (Abstract 95MO) Current FGFR inhibitor (FGFRi) therapies for patients with refractory or relapsed cholangiocarcinoma (CCA), or bile duct cancer, can lead to secondary FGFR2 mutations and treatment resistance. To address this, researchers led by Milind Javle, M.D., evaluated the efficacy and safety of tinengotinib, a next-generation FGFR2 inhibitor with unique target binding to overcome acquired resistance mutations. This Phase II trial enrolled patients who had received at least one prior line of chemotherapy, including those with prior FGFRi therapy. Patients with FGFR2 kinase domain mutations had the best overall response rate (ORR) at 44%. The ORR in patients with FGFR2-altered CCA was 29% and the disease control rate was 90%. For patients with prior FGFRi treatment, the ORR was 31%. The findings suggest tinengotinib may have a potential role in treating CCA patients with FGFR2 fusions, including those with prior FGFRi treatment. Researchers have launched the Phase III study of tinengotinib to further investigate this therapy. Javle will present the findings on Oct. 21.

    Perioperative immunotherapy improved outcomes in patients with late-stage melanoma (Abstract LBA48) 
    Patients with advanced melanoma face a significant risk of relapse even after surgery. Adding immunotherapy to surgery is considered more effective than surgery alone, but the proper timing of treatment is still unclear. In a follow-up analysis of a Phase II study led by Sapna Patel, M.D., researchers found neoadjuvant (pre-surgery) plus adjuvant (post-surgery) pembrolizumab lowered the chance of disease recurrence, progression or death, compared to adjuvant pembrolizumab alone for patients with stage IIIB-IV melanoma. Among those who had surgery and were evaluable for response, more than half had a major pathological response, which includes pathologic complete and near complete responses. These results suggest that perioperative (pre- and post-surgical) pembrolizumab should be considered when treating late-stage operable melanoma. Patel will present the updated findings on Oct. 23.  

    Intrathecal and intravenous immunotherapy improves survival in patients with leptomeningeal disease (Abstract 1082O) Leptomeningeal disease (LMD) occurs when cancer cells from tumors migrate into the cerebrospinal fluid (CSF) and leptomeninges, part of the lining of the brain and spinal cord. LMD can be challenging to diagnose and treat, and patients face poor survival rates. A recent proof-of-concept study showed that intrathecal (IT) nivolumab, which is administered directly into the CSF, along with intravenous (IV) immunotherapy helped improve survival in patients with LMD. Building upon this, Isabella Glitza Oliva, M.D., Ph.D., and colleagues continued the combination therapy in an IT dose expansion study. The median overall survival (OS) was 7.5 months, with a landmark OS rate of 68%, 54% and 35% at 3, 6 and 12 months, respectively. This study demonstrates the safety and efficacy of this combination of IT and IV therapy among 50 patients treated, confirming its feasibility and supporting ongoing clinical evaluation to further improve outcomes in this underserved patient population. Glitza Oliva will present updated clinical outcomes on Oct. 23.

    Triplet combination is safe and demonstrates clinical benefit in patients with refractory melanoma brain metastases (Abstract 1085O) While many patients with melanoma brain metastases (MBM) respond well to immune checkpoint blockade, many fail to respond or subsequently develop resistance, leaving them with limited systemic treatment options and a poor prognosis. In this Phase II study,a  research led by Elizabeth Burton examined the safety and efficacy of atezolizumab, bevacizumab and cobimetinib in 20 patients with treatment refractory MBM. The intracranial (IC) response rate and IC benefit rate were 38% and 53%, respectively. Safety was consistent with expectations, with 18 patients experiencing treatment-related adverse events (TRAEs) and 7 (35%) experiencing grade 3/4 TRAEs. Although the median PFS was 1.8 months, the median OS was 9.3 months. Eleven patients (55%) received treatment beyond progression, including stereotactic radiosurgery, after evaluation by MD Anderson’s multidisciplinary Brain Metastasis Clinic. These results, which highlight the tolerability of the combination, merit further clinical evaluation and underscore the importance of integrating multidisciplinary care into the evaluation of novel therapeutic strategies in this patient population. Burton will present updated findings on Oct. 23.

    Primary analysis of Phase II data of trastuzumab deruxtecan continues to show promising signals (Abstract LBA34) Trastuzumab deruxtecan (T-DXd), an antibody drug conjugate targeting HER2, has been approved for use in HER2-positive breast cancer, gastric cancer and HER2-mutant lung cancer. In the DESTINY-PanTumor02 study led by Funda Meric-Bernstam, M.D., T-DXd also showed potential as a treatment option in several other cancers, especially gynecological cancers. The objective response rate (ORR) across all patients was 37.1% with a duration of response of 11.3 months, but among patients with the highest levels of HER2 expression, ORR was 61.3% with a duration of 22.1 months. These data support the potential role of T-DXd as a tumor-agnostic therapy for patients with hard-to-treat HER2-expressing solid tumors that currently have limited treatment options. Interim data from this trial were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. Meric-Bernstam will present the primary analysis on Oct. 23.

    Eliminating surgery in select breast cancer patients shows low risk of cancer recurrence (Abstract 243MO)
    Approximately 60% of early-stage triple-negative and HER2-positive breast cancers have a positive response to chemotherapy. An exceptional response to chemotherapy is a strong indicator of a favorable prognosis and can be accurately confirmed through a minimally invasive image-guided vacuum-assisted core biopsy (VACB). In a Phase II trial led by Henry Kuerer, M.D., Ph.D., 50 patients underwent a VACB after completing chemotherapy. Previous reports of this research showed no breast cancer recurrence within two years. VACB identified a complete absence of cancer in 31 patients and, over three years, there were no recurrences in the same breast. The three-year disease-free survival and overall survival rates were both 100%. This study suggests that, for carefully selected breast cancer patients, avoiding surgery carries a minimal risk of disease recurrence. Further investigation and clinical trials are essential to validate this approach. Kuerer will present the three-year findings on Oct. 23.

     

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    University of Texas MD Anderson Cancer Center

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