Pluvicto plus standard care cuts PSA progression risk by 58% in metastatic hormone-sensitive prostate cancer.

Novartis announced that combining Pluvicto (lutetium-177 vipivotide tetraxetan) with standard care (ARPI + ADT) significantly improves PSA response in metastatic hormone-sensitive prostate cancer (mHSPC), reducing PSA progression risk by 58% compared to standard care alone. Data from the PSMAddition trial showed deeper and more durable PSA reductions at 12, 24, and 48 weeks, with a higher percentage of patients achieving very low PSA levels. Safety was consistent with previous studies, though grade ≥3 adverse events were slightly higher with Pluvicto. Regulatory submissions have been filed in the US, China, and Japan, with decisions expected in the second half of 2026, potentially redefining treatment standards for metastatic prostate cancer.