PMV Pharma’s Rezatapopt Phase 1 Shows Safety and Responses in 77 Patients
PMV Pharma released Phase 1 PYNNACLE results summarizing safety and efficacy of oral rezatapopt in 77 heavily pretreated patients with TP53 Y220C-mutant solid tumors. The study established a recommended Phase 2 dose, reported infrequent dose-limiting toxicities and objective responses across multiple KRAS wild-type tumor types.
1. Phase 1 PYNNACLE Data Release
PMV Pharma announced the release of Phase 1 results from its PYNNACLE study evaluating oral rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. Data from 77 heavily pretreated patients across dose-escalation cohorts were presented to establish safety, pharmacokinetics and biomarker effects.
2. Safety, Dose and Efficacy Findings
Rezatapopt was generally well tolerated with infrequent dose-limiting toxicities, supporting selection of a recommended Phase 2 dose. Objective responses were observed across multiple KRAS wild-type tumor types, demonstrating proof-of-concept for selective p53 reactivation in heavily pretreated patients.
3. Registrational Strategy and Timeline
PMV Pharma affirmed plans to advance rezatapopt into the pivotal Phase 2 portion of PYNNACLE and target a New Drug Application submission in platinum-resistant ovarian cancer by Q1 2027. The company remains focused on positioning rezatapopt as a first-in-class therapy for TP53 Y220C-mutant cancers with high unmet need.