PMV Pharmaceuticals Reports Promising Results in Ovarian Cancer Trial, Plans FDA Filing

PMV Pharmaceuticals has announced encouraging interim results from its phase 1/2 trial of rezatapopt, a novel p53 reactivator, in ovarian cancer patients. The biotech company is now setting its sights on a potential FDA approval filing in early 2027, buoyed by a 43% response rate in the midphase study.

Trial Results and Clinical Implications

The phase 1/2 trial, which began dosing patients in the phase 2 portion early last year, is evaluating rezatapopt in patients with solid tumors harboring a TP53 Y220C mutation. At the interim analysis, 19 out of 44 ovarian cancer patients responded to the therapy, including one complete response and 18 partial responses (one unconfirmed). The median duration of response in ovarian cancer patients was 7.6 months.

Deepika Jalota, chief development officer at PMV, expressed optimism about the results, stating, "It is very encouraging to see the depth and durability of tumor shrinkage observed across the ovarian cancer cohort in our phase 2 study. Not only did we observe deep responses, we see that responses were rapid and durable in our ovarian cancer patients to date."

Market Potential and Competitive Landscape

PMV estimates a significant market opportunity for rezatapopt, with approximately 1,700 second-line and later ovarian cancer patients with TP53 Y220C mutations in the U.S. and five major European markets. This translates to a potential U.S. market of $350 million to $420 million, with the global market reaching up to $630 million.

The company is positioning rezatapopt as a distinct alternative to both standard of care and emerging therapies in the platinum-resistant ovarian cancer market. Currently, this market is served by chemotherapy, AbbVie's Elahere, and AstraZeneca and Daiichi Sankyo's Enhertu. PMV argues that rezatapopt offers advantages as an oral, biomarker-directed chemo-alternative therapy with strong efficacy and a manageable safety profile.

Future Plans and Expansion

Based on the promising results, PMV plans to recruit an additional 20 to 25 ovarian cancer patients before completing enrollment in Q1 2026. The company aims to reach primary analysis for the cohort in Q4 2026 and file for FDA approval in Q1 2027.

Beyond ovarian cancer, PMV is exploring the potential of rezatapopt in other solid tumors. The company reported a 60% response rate in endometrial cancer, albeit in a small cohort of five patients. Response rates in larger cohorts of breast and lung cancer patients were around 20%.

As news of the trial results broke, shares in PMV rose 14% to $1.83 in premarket trading, reflecting investor optimism about the company's progress and potential in the oncology market.