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Novartis Pluvicto™ Shows Statistically Significant and Clinically Meaningful Radiographic Progression-Free Survival Benefit in Patients with PSMA–positive Metastatic Castration-Resistant Prostate Cancer

Reno, Nevada (UroToday.com) -- Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint.

Ad hoc announcement pursuant to Art. 53 LR

  • Phase III PSMAfore trial with PluvictoTM met the primary endpoint of radiographic progression-free survival (rPFS) in PSMA–positive mCRPC who have been treated with androgen-receptor pathway inhibitor (ARPI) therapy1
  • Pluvicto becomes the first PSMA-targeted radioligand therapy to demonstrate clinical benefit in mCRPC patients before receiving taxane-based chemotherapy,1 addressing a significant unmet need2
  • Findings to be presented at an upcoming medical meeting and submitted to regulatory authorities for approval in 2023
  • Novartis is advancing a broad portfolio of radioligand therapies to treat cancer and is investing in manufacturing capacity to meet the growing global demand for treatment
Reno, Nevada (UroToday.com) -- Novartis announced the pivotal Phase III PSMAfore study with PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan), a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy, met its primary endpoint. Pluvicto demonstrated a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) in patients with PSMA–positive metastatic castration-resistant prostate cancer (mCRPC) after treatment with androgen-receptor pathway inhibitor (ARPI) 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.1,3

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 death.1,3 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 (FDA) in 2023 for regulatory approval.


“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, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. “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.”
The vast majority of patients diagnosed with CRPC already present with metastases at time of diagnosis,4 patients with metastatic prostate cancer have an approximate 3 in 10 chance of surviving 5 years.5 Despite recent advances, outcomes for those who progress after standard of care second-generation ARPI remain poor, and there is an urgent need for new targeted treatment options to help improve long-term outcomes.6,7,8,9

Pluvicto is already approved for treatment in adult patients with PSMA–positive mCRPC who have been treated with ARPI and taxane-based chemotherapy in the United States and several other countries.10-12 


Source: “Novartis Pluvicto™ Shows Statistically Significant and Clinically Meaningful Radiographic Progression-Free Survival Benefit in Patients with PSMA–Positive Metastatic Castration-Resistant Prostate Cancer.” Novartis. Accessed December 5, 2022.