Key Takeaways
- Pluvicto plus standard of care cut PSA progression risk by 58% versus SoC alone.
- Deeper PSA response was seen in 87.4% of Pluvicto patients at 48 weeks.
- Regulatory filings in the US, China, and Japan await decisions in H2 2026.
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Novartis' Pluvicto Cuts PSA Progression Risk by 58% in Prostate Cancer Study
Novartis AG announced its drug Pluvicto lowered the risk of prostate-specific antigen (PSA) progression by 58% in a late-stage trial for metastatic hormone-sensitive prostate cancer (mHSPC).
"The deep and durable PSA response observed by combining 177Lu-PSMA-617 with today’s standard of care, together with earlier reported rPFS data, suggest that treatment intensification with radioligand therapy may help patients delay disease progression," said Fred Saad, Professor and Chairman of Surgery at the University of Montreal.
The Phase III PSMAddition trial showed that after 48 weeks, 87.4% of patients receiving Pluvicto plus standard of care (SoC) achieved a deep PSA reduction of less than 0.2 ng/mL, compared to 74.9% of patients on SoC alone. The hazard ratio for PSA progression, an early sign of disease resistance, was 0.42.
The positive data supports regulatory submissions in the US, China, and Japan, potentially expanding Pluvicto's use to an earlier stage of prostate cancer that affects approximately 186,000 new patients annually across key markets.
The combination therapy's safety profile was consistent with previous studies. Grade 3 or higher adverse events were reported in 50.7% of patients in the Pluvicto arm, compared to 43% on standard of care alone. The most common side effects included dry mouth, fatigue, nausea, hot flush, and anemia.
Pluvicto, or lutetium (177Lu) vipivotide tetraxetan, is an intravenous radioligand therapy that binds to PSMA-expressing cancer cells and delivers targeted radiation to kill them. It is currently approved for a later stage of the disease, known as metastatic castration-resistant prostate cancer (mCRPC).
The strong PSA response data reinforces Pluvicto's potential to become a new standard of care in the hormone-sensitive setting. Investors will watch for regulatory decisions in the second half of 2026, which could significantly boost Novartis's oncology franchise.
This article is for informational purposes only and does not constitute investment advice.
