PMV Pharmaceuticals Announces Updated Rezatapopt Monotherapy Interim Data From Ongoing PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation

Core Insights - PMV Pharmaceuticals announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial, focusing on rezatapopt for patients with advanced solid tumors harboring a TP53 Y220C mutation [1][4][6] Efficacy Data - The Phase 2 clinical trial data showed a 34% overall response rate (ORR) among 103 evaluable patients, with a median duration of response of 7.6 months [4][5] - In the ovarian cancer cohort, the ORR was 46% among 48 evaluable patients, with a median duration of response of 8.0 months [4][5] - Confirmed responses were observed across eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma [4][5] Safety Profile - The safety population included 112 patients treated with rezatapopt at a dose of 2000mg daily, with a median of three prior lines of systemic therapy [5][11] - Treatment-related adverse events (TRAEs) were mostly Grade 1-2, with the most frequent being nausea, fatigue, and increased blood creatinine [11] - The rate of drug discontinuations due to TRAEs was 3.6%, indicating manageable safety [11] Regulatory Plans - The company plans to submit a New Drug Application (NDA) for rezatapopt in the first quarter of 2027 for the treatment of platinum-resistant/refractory ovarian cancer [4][6] About Rezatapopt - Rezatapopt is a first-in-class small molecule designed to reactivate p53 by selectively binding to the p53 Y220C mutant protein, restoring its tumor-suppressor function [7][9] About the PYNNACLE Clinical Trial - The PYNNACLE trial is a Phase 1/2 study evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on safety, tolerability, and efficacy [8][9]