Phase III PSMAddition data presented at AUA 2026 showed that adding Pluvicto to standard therapy reduced the risk of PSA progression by 58% and increased deep PSA response rates in patients with PSMA-positive metastatic hormone-sensitive prostate cancer.
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
Novartis reported new Phase III data showing that adding Pluvicto to standard therapy improved prostate-specific antigen (PSA) responses in patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The findings from the PSMAddition trial (NCT04720157) were presented at the American Urological Association Annual Meeting 2026.
The trial evaluated Pluvicto combined with androgen receptor pathway inhibitor (ARPI) therapy plus androgen deprivation therapy (ADT) versus ARPI plus ADT alone. Results from the second interim analysis showed a 58% lower risk of PSA progression in the Pluvicto arm compared with standard therapy alone (HR 0.42; 95% CI: 0.30-0.59).
More patients receiving Pluvicto achieved deep PSA reductions, defined as PSA levels below 0.2 ng/mL. At Week 12, 47.6% of patients in the Pluvicto arm reached this threshold compared with 37.7% in the standard therapy group. Rates increased to 73.7% versus 59.7% at Week 24 and 87.4% versus 74.9% at Week 48.
Fred Saad, Professor and Chairman of the Department of Surgery at the University of Montreal, said the deep and durable PSA responses, together with previously reported radiographic progression-free survival data, suggest radioligand therapy may help delay disease progression when introduced earlier in treatment.
Safety findings were consistent with the established profile of Pluvicto observed in the PSMAfore and VISION studies. Grade 3 or higher adverse events occurred in 50.7% of patients receiving Pluvicto plus standard therapy compared with 43% in the control arm. Common adverse events included dry mouth, fatigue, nausea, hot flushes, and anemia.
Mark Rutstein, Global Head of Oncology Development at Novartis, said the results support the potential role of PSMA-targeted radioligand therapy as part of earlier treatment intensification strategies in metastatic prostate cancer.
Together with previously reported radiographic progression-free survival (rPFS) data, the deep and durable PSA responses observed in PSMAddition highlight the potential of Pluvicto to delay disease progression when introduced earlier in treatment. Regulatory submissions are underway in the United States, China, and Japan, with decisions anticipated in the second half of 2026. If approved, Pluvicto would become the first radioligand therapy to demonstrate Phase III benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer, expanding its use beyond its current indication in metastatic castration-resistant prostate cancer. Novartis is also evaluating Pluvicto in earlier-stage oligometastatic prostate cancer in the ongoing PSMA-DC trial (NCT05939414).
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.