Pluvicto (lutetium (177Lu) vipivotide tetraxetan) - (PSMAddition)

May 31, 2026: Novartis reported subgroup results from the Phase 3 PSMAddition trial of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) plus standard of care (androgen receptor pathway inhibitor + androgen deprivation therapy) vs standard of care alone in PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC), presented as an oral session at the 2026 ASCO Annual Meeting. Pluvicto showed consistent radiographic progression-free survival (rPFS) benefit across disease volume (high/low) and presentation (de novo/recurrent), consistent with the previously reported primary endpoint (28% reduction in risk of radiographic progression or death; HR 0.72, 95% CI 0.58–0.90; n=1,144). Reported subgroup rPFS HRs included high volume 0.72 (0.56–0.92) and low volume 0.73 (0.42–1.27), de novo 0.74 (0.54–1.01), recurrent 0.74 (0.53–1.04). Grade ≥3 adverse events were 50.7% with Pluvicto+SoC vs 43% with SoC; common all-grade AEs included dry mouth, fatigue, nausea, hot flush, anemia. Novartis said it has filed regulatory submissions in the US, China, and Japan based on PSMAddition, with first decisions expected in H2 2026.

Novartis also presented Phase 1 AcTION data for investigational 225Ac-PSMA-617 (actinium-based radioligand therapy) in PSMA-positive mCRPC, citing PSA declines, radiographic responses, and manageable safety; two Phase 3 trials are enrolling: PSMAcTION (post-Pluvicto/chemotherapy/ARPI) and AcTFirst (frontline mCRPC).