PMV Pharmaceuticals has announced significant findings from the Phase I, first-in-human segment of the ongoing Phase I/II PYNNACLE study, which evaluates the small molecule therapy rezatapopt in patients with advanced solid tumors that carry a TP53 Y220C mutation. The results, published in the New England Journal of Medicine, detail safety and efficacy data from 77 heavily pretreated patients, highlighting the drug’s potential in this challenging patient population.
The study demonstrated notable antitumor activity, particularly in patients with the TP53 Y220C mutation, establishing proof-of-concept for the selective reactivation of p53. Researchers reported that rezatapopt was generally well tolerated, with infrequent dose-limiting toxicities, which supports the recommended Phase II dose. Objective responses were observed across various tumor types, indicating a restoration of wild-type p53 function.
Deepika Jalota, Pharm.D., chief development officer of PMV Pharma, emphasized the importance of these findings, stating that they validate the company’s scientific strategy and support plans for a New Drug Application submission in platinum-resistant/refractory ovarian cancer by early 2027. This research underscores the potential of rezatapopt as a first-in-class therapy for patients with a high unmet medical need, particularly those harboring the TP53 Y220C mutation.
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