Novartis reports Phase 3 PSMAfore trial with Pluvicto met primary endpoint

Novartis announced the pivotal Phase 3 PSMAfore study with Pluvicto, a prostate-specific membrane antigen, or PSMA, targeted radioligand therapy, met its primary endpoint. Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival, or rPFS, in patients with PSMA-positive metastatic castration-resistant prostate cancer after treatment with androgen-receptor pathway inhibitor therapy, compared to a change in ARPI1. No unexpected safety findings were observed in PSMAfore; data are consistent with the already-well established safety profile of Pluvicto. "This is the second positive read-out for Pluvicto in a Phase III trial following the VISION study, where 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 death1,3. The PSMAfore results continue to support the important role of Pluvicto1 in treating patients with prostate cancer. The Phase III data will be presented at an upcoming medical meeting and discussed with the US Food and Drug Administration in 2023 for regulatory approval," the company said. "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. We look forward to discussing the data with healthcare authorities in order to bring this innovative new early treatment option to many more prostate cancer patients sooner after their diagnosis," added Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis.