PMV Pharma reports 46% ORR in ovarian cancer cohort of rezatapopt trial
Updated interim data from the PYNNACLE Phase 2 pivotal trial support plans for a first-quarter 2027 NDA submission seeking accelerated approval.
PMV Pharmaceuticals announced on August 31, 2026 updated interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE clinical trial.1 The trial is a multicenter, single-arm, registrational study testing rezatapopt as a monotherapy at 2000 mg taken once daily in patients with advanced solid tumors carrying the TP53 Y220C mutation.1
The company said enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion has been completed.1 Data cited in the release reflect a May 14, 2026 data cutoff.1 The efficacy population included 76 patients who either had at least one post-baseline tumor assessment or discontinued early.1
Per investigator assessment under RECIST version 1.1, the overall response rate was 46%, made up of 35 of 76 patients responding, with four patients showing confirmed complete responses, 29 showing confirmed partial responses, and two showing unconfirmed partial responses.1 Looking only at confirmed responses, the median time to response was 1.3 months, and the median duration of response reached 10.0 months.1
On safety, the company said rezatapopt has continued to show a favorable and consistent tolerability profile across all cohorts, with mostly Grade 1 and 2 treatment-related adverse events and a 5% discontinuation rate tied to those events.1 The ovarian cancer cohort's safety profile was similar to that of the broader patient population.1
On the regulatory front, PMV said a recent FDA meeting produced feedback supporting its plan to file a New Drug Application for accelerated approval in platinum-resistant/refractory ovarian cancer patients with the TP53 Y220C mutation, based on the Phase 2 portion of PYNNACLE.1 The company said it expects to submit that NDA in the first quarter of 2027.1 Separately, PMV plans to share data from all PYNNACLE Phase 2 cohorts, including the primary ovarian cancer analysis, at a medical conference in the fourth quarter of 2026.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.