Pluvicto, used in combination with standard therapy, reduces the risk of disease progression in men with advanced prostate cancer, according to data presented October 19 at the European Society for Medical Oncology 2025 annual meeting in Berlin.
In the latest results from the company’s phase III PSMAddition trial, Pluvicto (lutetium-177 PSMA-617) plus androgen receptor pathway inhibitor and androgen deprivation therapy (standard therapy [SoC]) reduced the risk of radiographic progression or death by 28% versus SoC alone in patients with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive disease, Novartis reported.
As well, more patients achieved a complete response versus SoC alone (57.1% vs. 42.3%), and the overall response rate was numerically higher in the Pluvicto plus SoC arm (85.3% vs. 80.8%), according to the company. Further, Pluvicto delayed the time patients progressed to metastatic castration-resistant prostate cancer (hazard ratio, 0.7), Novartis said.
The release of the results follows the company’s general announcement in June that Pluvicto met its primary endpoint in the trial.
“These new results strengthen the evidence base for Pluvicto and demonstrate its potential to improve outcomes in an even earlier stage of metastatic prostate cancer,” Novartis stated.
Pluvicto was first approved in 2022 for adult patients with PSMA-positive metastatic castration-resistant prostate cancer who have previously received standard of care treatments. In March, it was approved for use after one androgen receptor pathway inhibitor treatment as well as prior to chemotherapy.
Novartis plans to submit data from the PSMAddition trial to regulatory authorities before the end of the year.
