PMV Pharma Announces Interim Data From Phase 2 Pivotal Portion Of PYNNACLE Clinical Trial; Plans To Submit NDA For Platinum Resistant/Refractory Ovarian Cancer By End Of Q1 2027
Benzinga Newsdesk 1 year ago
News
PYNNACLE Phase 2 pivotal clinical trial interim data include confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary
- PYNNACLE Phase 2 pivotal clinical trial interim data include confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma
- 33% overall response rate (ORR) observed among 97 evaluable patients across all cohorts with a median duration of response of 6.2 months
- 43% ORR observed among 44 evaluable patients in ovarian cancer cohort with a median duration of response of 7.6 months
- Rezatapopt New Drug Application submission for platinum resistant/refractory ovarian cancer planned in first quarter of 2027
- Company to host investor webinar at 8:00 AM ET today to review Phase 2 interim clinical data
PRINCETON, N.J., Sept. 10, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (("PMV Pharma" or the "Company", NASDAQ:PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today announced interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial. The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation.
The Phase 2 clinical trial data below are summarized as of an August 4, 2025 data cutoff date:
The safety population consisted of 109 patients treated with at least one dose of rezatapopt 2000 mg daily as monotherapy.
Median number of prior lines of systemic therapy was three (range: 1-10)
The efficacy population consisted of 97 patients treated with at least one dose of rezatapopt as of the data cutoff date and either had ≥1 post-baseline tumor assessment or discontinued early.