Expansion of Pluvicto Use Sought by Novartis Following Positive Prostate Cancer Study Update

1. Novartis intends to file for a broader application of Pluvicto based on encouraging patient survival data from the Phase 3 PSMAfore trial.
2. Pluvicto, known generically as lutetium (¹⁷⁷Lu) vipivotide tetraxetan, previously approved for patients with PSMA-positive mCRPC who had prior treatments with androgen receptor pathway inhibitors (ARPI) and taxane-based chemotherapy.
3. The PSMAfore trial met its primary endpoint of rPFS, demonstrating a 59% reduction in the risk of radiographic disease progression when using Pluvicto versus a change of ARPI.
4. An updated rPFS analysis showed that Pluvicto more than doubled median rPFS to 12.0 months, compared to 5.6 months for the control group.
5. Overall survival (OS) data interpretation from PSMAfore continues as it collects additional OS information.
6. Novartis plans to present these results at an upcoming medical meeting and discuss them with regulatory authorities like the US Food and Drug Administration (FDA).
7. The company also aims to explore opportunities to investigate Pluvicto radioligand therapy in earlier stages of prostate cancer.
8. Despite recent advances, outcomes for patients who progress after standard-of-care second-generation ARPI remain poor, highlighting the need for new targeted treatment options.