PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation

• 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.

Efficacy

• Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma.
• Overall response rate (ORR) of 33% (32/97 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses.
• The cohort-specific ORRs were as follows:
  • Ovarian cancer: 43% ORR (19/44 patients, including one confirmed complete response, 17 confirmed partial responses, and one unconfirmed partial response [uPR])
  • Breast cancer: 18% ORR (2/11 patients)
  • Endometrial cancer: 60% ORR (3/5 patients, including one uPR)
  • Lung cancer: 22% ORR (4/18 patients, including three uPRs)
  • Other solid tumors: 21% ORR (4/19 patients)
• Across all cohorts, the median time to response was 1.4 months and the median duration of response was 6.2 months.
• In the ovarian cancer cohort, the median time to response was 1.3 months and median duration of response was 7.6 months.
• Post the August 4, 2025 data cutoff date, the patients with uPRs remain on treatment.

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