PMV reports 46% interim response rate for rezatapopt in ovarian cancer trial

  • PMV Pharmaceuticals reported interim rezatapopt data from the PYNNACLE ovarian cancer cohort.
  • 46% overall response rate was observed among 76 evaluable patients.
  • PMV plans an NDA submission for accelerated approval in the first quarter of 2027.

Rezatapopt produced a 46% overall response rate among 76 evaluable patients with platinum-resistant or refractory ovarian cancer in an interim analysis of PMV Pharmaceuticals’ Phase 2 pivotal PYNNACLE trial. The responses included four confirmed complete responses, 29 confirmed partial responses and two unconfirmed partial responses, with a median time to response of 1.3 months and median duration of response of 10.0 months based on confirmed responses. The data cutoff was May 14, 2026. PMV said recent FDA feedback supports its strategy to seek accelerated approval through a New Drug Application planned for the first quarter of 2027. The company plans to present an update covering all PYNNACLE Phase 2 pivotal cohorts, including primary ovarian-cancer analysis data, at a medical conference in the fourth quarter of 2026. Rezatapopt is an oral p53 reactivator being studied at 2,000 milligrams once daily in patients whose advanced solid tumors harbor a TP53 Y220C mutation.

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