Rezatapopt (PC14586) - (PYNNACLE)

August 31, 2026: PMV Pharmaceuticals (NASDAQ: PMVP) reported updated interim Phase 2 pivotal PYNNACLE data for rezatapopt (PC14586) monotherapy in TP53 Y220C platinum-resistant/refractory ovarian cancer. Among 76 evaluable patients (data cutoff May 14, 2026), investigator-assessed ORR was 46% (35/76), including 4 confirmed complete responses, 29 confirmed partial responses, and 2 unconfirmed partial responses per RECIST v1.1. Median time to response was 1.3 months, and median duration of response was 10.0 months based on confirmed responses.

The company said enrollment for the ovarian cancer primary analysis has been completed. Safety was described as favorable and consistent, with mostly Grade 1/2 treatment-related adverse events and a 5% discontinuation rate due to treatment-related AEs; the ovarian cohort safety profile was similar to the overall population.

Regulatory update: after a recent FDA meeting, PMV said the agency’s feedback continues to support its strategy to submit an NDA for accelerated approval of rezatapopt in TP53 Y220C platinum-resistant/refractory ovarian cancer based on Phase 2 PYNNACLE data. The NDA is planned for Q1 2027.

Upcoming catalyst: PMV plans to present an update on all PYNNACLE Phase 2 pivotal cohorts, including primary analysis data from the ovarian cohort, at a medical conference in Q4 2026.