PMV Pharma reports 33% ORR in Phase 2 interim data, plans NDA submission in 2027.

PYNNACLE Phase 2 clinical trial interim data show an 33% overall response rate among 97 evaluable patients across eight tumor types. In the ovarian cancer cohort, a 43% response rate was observed with a median duration of response of 7.6 months. A New Drug Application for platinum-resistant/refractory ovarian cancer is planned for Q1 2027.

PRINCETON, N.J., Sept. 10, 2025 — PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, has 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, as of an August 4, 2025 data cutoff date, show confirmed responses in eight tumor types, including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma. Among 97 evaluable patients across all cohorts, an overall response rate (ORR) of 33% was observed, with a median duration of response of 6.2 months. In the ovarian cancer cohort, the ORR was 43%, with a median duration of response of 7.6 months PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

Rezatapopt, a first-in-class, small molecule p53 reactivator, has shown promising results in addressing cancers with high unmet need. The drug selectively binds to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.

PMV Pharma plans to enroll an additional 20-25 platinum-resistant/refractory ovarian cancer patients who have received prior standard of care by the end of the first quarter of 2026. The company aims to submit a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer by the end of the first quarter of 2027 PMV Pharmaceuticals Announces Promising Rezatapopt Monotherapy Interim Data From PYNNACLE Phase 2 Trial Across Multiple Solid Tumors With a TP53 Y220C Mutation^[1].

The company will host an investor webinar today at 8:00 AM ET to review the PYNNACLE Phase 2 interim data and provide a regulatory update. The event will feature presentations by PMV Pharma management and Ramez N. Eskander, M.D., Professor of Obstetrics, Gynecology, and Reproductive Sciences at University of California, San Diego.

About PMV Pharma:
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The company is headquartered in Princeton, New Jersey. For more information, please visit www.pmvpharma.com.

Forward-Looking Statements:
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