Overview
- The study met its primary endpoint with a 28% reduction in risk of radiographic progression or death versus ARPI plus ADT alone (HR 0.72; 95% CI 0.58–0.90; p=0.002).
- Time to development of metastatic castration-resistant prostate cancer was prolonged with Pluvicto (HR 0.70; 95% CI 0.58–0.84).
- Overall survival showed a favorable but still immature trend in the combination arm (HR 0.84; 95% CI 0.63–1.13).
- Grade 3 or higher adverse events occurred in 50.7% on Pluvicto plus standard care versus 43% on standard care, with dry mouth, fatigue, nausea, hot flushes and anemia among common events.
- The open-label Phase III trial randomized 1,144 PSMA-positive patients 1:1 to Pluvicto plus ARPI and ADT versus ARPI and ADT alone, with higher complete and overall response rates reported for the combination.