▎WuXiEdited by Kant Content Team

Recently, Novartis announced the results of its Phase 3 PSMAfore clinical trial, showing that its targeted radioligand therapy Pluvicto (177Lu-PSMA-617) significantly improved overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC).Novartis is expected to submit the expanded indication application for Pluvicto in the second half of 2024.

The PSMAfore trial, which was announced this time, is an open-label, multi-center Phase 3 trial aimed at comparing Pluvicto with the use of changesTypeTheAndrogen Receptor Pathway Inhibitors (ARPI)Treatment plan, inProstate-Specific Membrane Antigen (PSMA)Efficacy and Safety in Patients with mCRPC.These patients had previously received treatment with ARPI.

▲Introduction to Pluvicto Therapy (Image Source: Novartis Official Website)

The pre-specified analysis results show,In the unadjusted intention-to-treat (ITT) population, the OS hazard ratio for patients was less than 1.0 (HR<1.0).Moreover, the radiographic progression-free survival (rPFS) and other secondary efficacy endpoints are consistent with the interim analysis results announced in 2023. After an additional 8 months of follow-up, the safety profile of Pluvicto also remains consistent with the previously reported trial results.

Last October, Novartis announced at the European Society for Medical Oncology (ESMO) Congress,Pluvicto achieved the primary endpoint of rPFS (HR=0.41, 95% CI: 0.29-0.56; p<0.0001).

▲The efficacy results of Pluvicto announced at last year's ESMO conference (Image source: ESMO official website)

Pluvicto combines a small molecule compound that targets PSMA with a radioactive isotope. It can bind to prostate cancer cells expressing PSMA, and the radiation energy released by the radioactive isotope damages the tumor cells, triggering cell death.Since the radiation released by Pluvicto only acts over a very short distance, it limits the damage to surrounding healthy cells. This therapy previously received Breakthrough Therapy Designation from the FDA. In March 2022, the FDA approved Pluvicto.Listed, for the treatment of PSMA-positive mCRPC patients who have received taxane-based chemotherapy and androgen receptor signaling pathway inhibitor therapy.

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