PMV Pharmaceuticals reveals new interim data on rezatapopt monotherapy
Clinical Trial Update: PMV Pharmaceuticals presented updated data from the Phase 2 pivotal portion of the PYNNACLE clinical trial, evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, at the 2025 AACR-NCI-EORTC conference.
Efficacy Results: The trial showed an overall response rate of 34% across various tumor types, with specific rates of 46% for ovarian cancer and 60% for endometrial cancer, and a median duration of response of 7.6 months.
Safety Profile: Treatment-related adverse events were primarily Grade 1-2, with nausea and fatigue being the most common; the rate of discontinuation due to adverse events was low at 3.6%.
Improved Tolerability: Administration of rezatapopt with food improved gastrointestinal tolerability compared to earlier Phase 1 data, with manageable and mostly transient lab abnormalities.
Discover Tomorrow's Bullish Stocks Today
Analyst Views on PMVP
About PMVP
About the author
PMV Pharmaceuticals Reveals New Interim Data on Rezatapopt Monotherapy from Ongoing PYNNACLE Phase 2 Trial for Various Solid Tumors with TP53 Y220C Mutation
Clinical Trial Results: Updated data from the Phase 2 PYNNACLE trial presented at the 2025 AACR-NCI-EORTC Conference showed a 34% overall response rate (ORR) across eight tumor types, with a notable 46% ORR in the ovarian cancer cohort.
Rezatapopt Overview: Rezatapopt (PC14586) is a first-in-class small molecule designed to reactivate the p53 protein in tumors with the TP53 Y220C mutation, with plans for a New Drug Application submission for platinum-resistant ovarian cancer in Q1 2027.
Safety Profile: The treatment was generally well-tolerated, with most adverse events being Grade 1-2, and a low discontinuation rate due to treatment-related adverse events (3.6%).
Future Directions: PMV Pharma aims to continue generating data to support regulatory strategies and enhance treatment options for patients with advanced solid tumors harboring the TP53 Y220C mutation.
PMV Pharmaceuticals' Small-Cap Cancer Drug Demonstrates Verified Efficacy Across 8 Tumor Types
Clinical Trial Results: PMV Pharmaceuticals released interim data from the Phase 2 PYNNACLE trial, showing a 33% overall response rate for rezatapopt in patients with advanced solid tumors harboring the TP53 Y220C mutation, with notable efficacy in ovarian (43% ORR) and endometrial (60% ORR) cancers.
Safety and Regulatory Plans: The treatment was generally well-tolerated, with most adverse events being mild. PMV Pharma plans to enroll additional patients for a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer by early 2027, following FDA feedback.
