By Fineline Cube 
Novartis (NYSE: NVS) today disclosed the first data from its Phase III PSMAddition trial of lutetium‑177 vipivotide tetraxetan (Lu‑177 VIP) at the European Society for Medical Oncology (ESMO) 2025 Congress. The trial demonstrated that Lu‑177 VIP, when combined with standard of care (SoC), produced a statistically significant and clinically meaningful improvement in patients with PSMA‑positive metastatic hormone‑sensitive prostate cancer (mHSPC).
Key ESMO 2025 Findings
| Endpoint | Lu‑177 VIP + SoC | SoC Alone | Hazard Ratio (HR) | 95 % CI |
|---|---|---|---|---|
| Radiographic Progression‑Free Survival (rPFS) | 28 % risk reduction | — | 0.72 | 0.58 – 0.90 |
| Overall Survival (OS) | Early positive trend | — | 0.84 | 0.63 – 1.13* |
| Complete Response (CR) | 57.1 % | 42.3 % | — | — |
| Overall Response Rate (ORR) | 85.3 % | 80.8 % | — | — |
| Time to mCRPC | 30 % risk reduction | — | 0.70 | 0.58 – 0.84 |
*OS follow‑up continues until data maturity.
The rPFS benefit was consistent across all prespecified subgroups, and the combination regimen also delayed progression to metastatic castration‑resistant prostate cancer (mCRPC).
Strategic Impact
- First‑In‑Class Targeted Radioligand Therapy – Lu‑177 VIP delivers targeted beta‑particle radiation directly to PSMA‑expressing tumor cells, sparing healthy tissue.
- Potential to Shift Treatment Paradigm – The data support the use of Lu‑177 VIP earlier in the disease course, potentially improving outcomes for patients who are still hormone‑sensitive.
- Regulatory Momentum – Positive Phase III data bolster the regulatory strategy for global accelerated approval and support ongoing late‑stage studies.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech