PMV Pharmaceuticals Announces Updated Data From The Phase 2 Pivotal Portion Of The Ongoing PYNNACLE Clinical Trial In Patients With Advanced Solid Tumors Harboring A TP53 Y220C Mutation; Overall Response Rate Of 34% (35/103 Patients) Per Investigator Assessment According To Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1, Including Confirmed And Unconfirmed Responses

Author: Benzinga Newsdesk | October 24, 2025 10:44am

• Data presented today as an oral presentation at 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 
• Confirmed responses observed in eight tumor types spanning ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary carcinoma
• 34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months
• 46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months
• Rezatapopt New Drug Application submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027
  
   

PRINCETON, N.J., Oct. 24, 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 updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial. Results were presented today in an oral presentation by Alison M. Schram, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center and PYNNACLE Study Investigator, at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston, Massachusetts. The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation.

"Patients with TP53 Y220C-mutated advanced solid tumors are in need of better treatment options, particularly those with platinum-resistant and refractory ovarian cancer. The rezatapopt data presented today demonstrate very encouraging clinical activity, reinforcing the potential for rezatapopt to target the underlying biology of these cancers and providing a potential shift in the current treatment paradigm," said Dr. Schram.

The Phase 2 clinical trial data below are summarized as of a September 4, 2025 data cutoff date:

• The safety population consisted of 112 patients treated with at least one dose of rezatapopt 2000mg daily as monotherapy.
  • Median number of prior lines of systemic therapy was three (range: 1-10)
• The efficacy population consisted of 103 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 cancers, and ampullary carcinoma.
• Overall response rate (ORR) of 34% (35/103 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: 46% ORR (22/48 patients, including one confirmed complete response, 18 confirmed partial responses, and three unconfirmed partial responses [uPR])
  • Breast cancer: 17% ORR (2/12 patients)
  • Endometrial cancer: 60% ORR (3/5 patients, including one uPR)
  • Lung cancer: 21% ORR (4/19 patients, including one uPR)
  • Other solid tumors: 21% ORR (4/19 patients)
• Across all cohorts, the median time to response was 1.3 months and the median duration of response was 7.6 months.
• In the ovarian cancer cohort, the median time to response was 1.3 months and median duration of response was 8.0 months.
• Post the September 4, 2025 data cutoff date, four uPRs were confirmed and one uPR (ovarian cancer) remains on treatment.
  
   

Safety

• Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>15%) being nausea, fatigue, blood creatinine increased, and alanine aminotransferase (ALT) increased. The rates of individual Grade 3 TRAEs were ≤6%. All Grade 3 TRAEs resolved on treatment and there were no discontinuations due to Grade 3 aspartate aminotransferase (AST)/ALT elevations.
• Rezatapopt administration with food led to an improvement in gastrointestinal tolerability relative to Phase 1 data.
• Lab abnormalities were manageable, with the majority of cases being transient and reversible.
• The rate of drug discontinuations due to a TRAE was 3.6%.

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