PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom
PMV Pharmaceuticals' p53 reactivator, rezatapopt, achieved a 43% response rate in a midphase (Phase 2) trial for ovarian cancer patients with the TP53 Y220C mutation, including one confirmed complete response and a median response duration of 7.6 months125.
The ongoing PYNNACLE trial also showed responses across other solid tumors, with a 33% overall response rate among 97 evaluable patients, and the greatest efficacy seen in ovarian and endometrial cancers25.
PMV plans to file for FDA approval of rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027, after enrolling an additional 20-25 patients and analyzing data estimated by late 2026135.
Tolerability at the 2g daily dose was acceptable, with gastrointestinal side effects improved by food and manageable liver enzyme elevations, although earlier trials had shown some dose-limiting toxicities3.
Despite the data, PMV's stock price remains volatile and is significantly below its 2023 levels, reflecting persistent investor concerns about both clinical and financial risk, especially as PMV’s financial runway is running low and there are fears of share dilution34.
Sources:
1. https://www.fiercebiotech.com/biotech/pmv-plots-ovarian-cancer-filing-after-seeing-midphase-data
2. https://www.biospace.com/press-releases/pmv-pharmaceuticals-announces-promising-rezatapopt-monotherapy-interim-data-from-pynnacle-phase-2-trial-across-multiple-solid-tumors-with-a-tp53-y220c-mutation
3. https://www.oncologypipeline.com/apexonco/rezatopopt-sees-path-forward-after-all
4. https://www.oncologypipeline.com/apexonco/pmv-hopes-rezatapopt-redemption
5. https://www.cancernetwork.com/view/rezatapopt-yields-responses-across-tp53-y220c-mutated-solid-tumor-types