PMV Pharma reports 46% ORR for rezatapopt in ovarian cancer cohort

PMV Pharmaceuticals has disclosed updated interim efficacy and safety data for rezatapopt in the ovarian cancer cohort of its registrational PYNNACLE Phase 2 trial, reporting an overall response rate of 46% across 76 evaluable patients as of a 14 May 2026 data cutoff.

Of the 35 responders, four achieved confirmed complete responses and 29 confirmed partial responses, with a further two unconfirmed partial responses counted in the investigator assessment under RECIST v1.1 criteria. The median time to first response was 1.3 months, and the median duration of response reached 10.0 months based on confirmed responses. Enrolment of platinum-resistant/refractory ovarian cancer patients for the primary analysis has now been completed.

Safety and regulatory progress

PMV reported that rezatapopt continues to show a manageable tolerability profile, with treatment-related adverse events predominantly Grade 1 or 2 and a discontinuation rate of 5% due to treatment-related adverse events. The company described the safety profile in the ovarian cancer cohort as consistent with that seen across the broader trial population.

On the regulatory front, a recent meeting with the US Food and Drug Administration yielded feedback that the agency said continued to support PMV's strategy for submitting a New Drug Application seeking accelerated approval of rezatapopt in patients with platinum-resistant/refractory ovarian cancer harbouring a TP53 Y220C mutation. PMV anticipates filing the NDA in the first quarter of 2027. The drug already holds FDA Fast Track designation for advanced solid tumours with a p53 Y220C mutation, as well as Orphan Drug Designation for TP53 Y220C-positive ovarian, fallopian tube, and primary peritoneal cancers.

The company said full primary analysis data from the ovarian cancer cohort, along with updates on the four remaining PYNNACLE cohorts covering lung, breast, endometrial cancers and other solid tumours, will be presented at a medical conference in the fourth quarter of 2026.

Market context

Rezatapopt is positioned as a first-in-class small molecule p53 reactivator, selectively binding to the conformational pocket created by the Y220C missense mutation and aiming to restore wild-type tumour-suppressor activity. The TP53 Y220C variant is relatively rare, estimated to account for a small fraction of the roughly 50% of all cancers that carry some form of TP53 mutation, which defines the addressable population and makes Orphan Drug status commercially meaningful.

The platinum-resistant/refractory ovarian cancer setting remains one of the most difficult-to-treat indications in oncology, and regulators have historically been willing to grant accelerated approvals on the basis of single-arm response rate data in this context, most notably for antibody-drug conjugates and PARP inhibitors in earlier lines. A 46% ORR with a 10-month duration of response in a biomarker-selected, heavily pre-treated population is likely to attract attention from both clinicians and potential commercial partners, though the company has not named any partnership discussions.

Investors will be watching the Q4 2026 conference readout closely for the primary analysis data, including durability of response beyond the current cutoff, as well as any overall survival signals that could strengthen the post-approval confirmatory trial strategy. The NDA timeline positions a potential approval decision in late 2027 or early 2028, depending on FDA review clock and any requests for additional data.