PMV Pharmaceuticals, Inc. (NASDAQ:PMVP) on Wednesday released interim data from the Phase 2 pivotal portion of the PYNNACLE clinical trial evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation.
As of the data cutoff date of August 4, 2025, the safety population consisted of 109 patients treated with at least one dose of rezatapopt 2000 mg daily as monotherapy.
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.
The overall response rate (ORR) was 33%. 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 the median duration of response was 7.6 months.
Safety
Treatment-related adverse events (TRAEs) were mainly grade 1-2, with the most frequent TRAEs observed (>15%) being nausea, fatigue, increased blood creatinine, and increased alanine aminotransferase.
Regulatory Update
During a recent meeting with the U.S. Food and Drug Administration (FDA), PMV Pharma received feedback regarding the initial New Drug Application (NDA) submission strategy for platinum-resistant/refractory ovarian cancer.
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 plans to submit an NDA for platinum-resistant/refractory ovarian cancer by the end of the first quarter of 2027.
Price Action: PMVP stock is down 23.30% at $1.23 at the last check on Wednesday.
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