Promontory Therapeutics Announces Successful End of Phase 2 Meeting with US FDA on Phase 3 Registrational Study Design for PT-112 in Patients with Metastatic Castration-Resistant Prostate Cancer

On May 20, 2025 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule oncology approaches with immunotherapeutic effects, reported a successful in-person End of Phase 2 (EOP2) Meeting with the U.S. Food and Drug Administration (FDA), allowing the company to prepare and submit a registrational Phase 3 study of PT-112 monotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC) (Press release, Promontory Therapeutics, MAY 20, 2025, View Source [SID1234653250]).

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Consistent with FDA Project Optimus, the FDA agreed with the proposed dosing regimen for use in a prospective, randomized controlled Phase 3 registrational study, on the basis of the completed Phase 2 clinical trial. The study design and endpoints, along with the proposed comparator and statistical framework, were agreed in principle, as were Promontory’s proposed patient population within mCRPC, and proposal for an interim analysis. The latter would allow a potential pathway for drug approval prior to the full completion of the Phase 3 study.

Promontory will now prepare its full Phase 3 study submission for final review on the basis of FDA’s guidance, and conduct similar meetings with international regulatory authorities.

The proof of concept and dose optimization Phase 2 study of PT-112 monotherapy in advanced mCRPC was conducted in the U.S. and France and included three randomized dosing arms of PT-112. Immune response biomarker data were recently presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) 2025 Annual Meeting, and preliminary clinical outcomes will be presented on June 2nd at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Annual Meeting.

For more information about Promontory Therapeutics and PT-112 visit www.PromontoryTx.com.