Novartis AG (NVS) presented new subgroup analyses from its pivotal PSMAddition Phase 3 trial, showing that Pluvicto (lutetium Lu 177 vipivotide tetraxetan) plus standard of care (SoC) consistently improved outcomes in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The findings were highlighted at the 2026 American Society of Clinical Oncology (ASCO) annual meeting.
Prostate cancer is the second most common cancer in men worldwide, and patients with mHSPC often progress quickly despite initial therapy. In this large, randomized trial of more than 1,100 PSMA-positive patients, Pluvicto reduced the risk of radiographic progression or death by 28% compared to standard therapy alone (HR 0.72, 95% Cl: 0.58-0.90). Importantly, the benefit was consistent across all subgroups, including patients with high-volume and low-volume disease, as well as those with newly diagnosed or recurrent cancer.
Safety results were in line with expectations, Grade =3 adverse events occurred in 50.7% of patients receiving Pluvicto plus standard therapy versus 43% with standard therapy alone. The most common side effects including dry mouth, fatigue, nausea, hot flushes, and anemia. No new safety signals were observed.
Fred Saad, Professor and Chairman at the University of Montreal, commented: "The consistent findings demonstrated with Pluvicto across key subgroups, regardless of initial presentation or disease volume, reinforce its potential as a cornerstone of early treatment for a broad range of patients."
Novartis has already filed regulatory submissions in the U.S., China, and Japan based on these results, with decision expected in the second half of 2026. The company continues to expand its radioligand therapy portfolio, positioning Pluvicto as a potential standard of care in earlier stages of prostate cancer.
NVS has traded between $112.34 and $170.46 over the past year. The stock closed Friday's trading (May 29, 2026) at $150.17, down 0.81%. In pre-market the stock is at $147.67, down 1.66%.
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