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

Excerpt from the Press Release:

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.

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