Company: PMVP
Filing Date: 2025-03-03
Form Type: 10-K
Source: 0000950170-25-030414
Chunk: 14

Company: PMV Pharmaceuticals, Inc.
Filing Date: 2025-03-03
Form: 10-K
Item: Item 1
Chunk 14
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 patient in this clinical trial in the fourth quarter of 2020.

Phase 1 Completion. In July 2023, we concluded our End of Phase 1 meeting with the FDA with alignment on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting.

The updated Phase 1 data, as of a September 5, 2023 data cutoff date, included enrollment of 67 patients with the p53 Y220C mutation, 51 of whom had measurable disease of which 38 were also KRAS wild type. Patients in the study had a median age of 63 (range of 32-84 years of age) with a range of tumor types and were heavily pretreated with a median of three prior lines of therapy. Of these patients, 38 patients with measurable disease and were KRAS wild type, were treated in the efficacious dose range, which was defined as a dose from 1150mg QD to 1500mg BID. In the efficacious dose range, confirmed partial responses were observed per investigator assessment (RECIST v1.1) in 13 patients (34%) across multiple different tumor types including breast, endometrial, ovarian, small cell lung and prostate cancer. After the data cutoff date, a confirmed partial response was also observed in a head and neck cancer patient. Best response of stable disease, or SD, or confirmed partial response was observed in 33 of the 38 patients (87%) in the efficacious dose range. We also evaluated patients at the recommended Phase 2 dose of 2000 mg QD. Among the 16 patients treated at the recommended Phase 2 dose level, confirmed partial responses were observed per investigator assessment (RECIST v1.1) in 6 patients (38%) across multiple tumor types, including those noted above. Best response of SD or confirmed partial response was observed in 14 of the 16 patients (88%).

 6

Rezatapopt was observed to be generally well-tolerated (across 67 patients treated with rezatapopt monotherapy as of September 5, 2023). The majority of adverse events were mild or moderate (Grade 1 or 2) in severity with the most frequent