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.
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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.
