PRINCETON, N.J. - PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a leader in precision oncology, has announced promising results from a Phase 1 analysis of rezatapopt (PC14586) in patients with advanced ovarian cancer harboring the TP53 Y220C mutation. The findings were presented at the Society for Gynecologic Oncology (SGO) Annual Meeting.
The study evaluated heavily pre-treated ovarian cancer patients and observed a confirmed partial response in seven out of 15 patients, with a median response duration of seven months. Rezatapopt also demonstrated a favorable safety profile.
Dr. Alison M. Schram from Memorial Sloan Kettering Cancer Center, who delivered the presentation, highlighted the significant unmet medical need for these patients, particularly those who are platinum-resistant.
Deepika Jalota, Chief Development Officer at PMV Pharma, stated that these results support further investigation of rezatapopt as a monotherapy in ovarian cancer. The company is preparing to initiate a registrational Phase 2 trial later this year, which will include an ovarian cancer cohort.
The Phase 1 data from the PYNNACLE trial (NCT04585750) also showed that rezatapopt induced responses across multiple tumor types within the TP53 Y220C mutation and KRAS wild-type patient population. The trial assessed the safety and efficacy of rezatapopt at various dosages, with the most frequent treatment-related adverse events being nausea, vomiting, and increased blood creatinine.
Rezatapopt is a first-in-class small molecule that aims to restore the normal function of the p53 protein, which is often mutated in cancers. The FDA has granted Fast Track designation for rezatapopt for the treatment of patients with advanced solid tumors with a p53 Y220C mutation.
The ongoing Phase 1/2 PYNNACLE study is evaluating the maximum tolerated dose and recommended Phase 2 dose of rezatapopt, with the primary objective of the Phase 2 expansion study being to evaluate the efficacy of the therapy in patients with advanced solid tumors harboring the TP53 Y220C mutation.
This article is based on a press release statement from PMV Pharmaceuticals, Inc.
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