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Novartis (NYSE:NVS) said on Monday that its radioligand therapy Pluvicto (INN: lutetium 177Lu) met the main goal of a phase 3 trial in certain patients with prostate cancer.
The study, dubbed PSMAfore evaluated Pluvicto in patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI. The trial enrolled 469 people. Patients had progressed only once after receiving a second-generation ARPI.
The Swiss pharma giant said Pluvicto showed a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) in the patients, compared to a change in ARPI.
PFS is the length of time during/after treatment a patient lives with the disease without it getting worse.
A key secondary goal of overall survival, was ongoing as data remain immature, the company added.
No unexpected safety findings were seen in PSMAfore and data was consistent with the safety profile of the drug.
Pluvicto is already approved to treat adult patients with PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy in the U.S. and certain other countries.
Novartis said this is the second positive read-out for Pluvicto in a Phase 3 trial after the study called VISION, in which patients with PSMA–positive mCRPC who received Pluvicto plus standard of care after being treated with ARPI and taxane-based chemotherapy had a statistically significant reduction in risk of death.
“With the announcement of these positive topline Phase III results, Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate significant and clinically meaningful benefits for people living with this type of prostate cancer who have not received taxane-based chemotherapy,” said Shreeram Aradhye, president, Global Drug Development and chief medical officer, Novartis.
The company plans to submit the data to regulatory authorities for approval in 2023.