PMV Pharmaceuticals (PMVP) TD Cowen's 6th Annual Oncology Innovation Summit summary

Trial progress and enrollment

• Site activation for the pivotal phase II trial is nearly complete, with enrollment on target to finish by year-end.

• The interim analysis will include 50 patients with at least 18 weeks of follow-up, up from the initially planned 30.

• Approximately 40% of interim patients are from the ovarian cancer cohort.

• All five cohorts (ovarian, lung, breast, endometrial, and other) will be reported at interim.

• Site selection prioritized centers with next-generation sequencing and relevant oncology subspecialists.

Data expectations and regulatory strategy

• Interim data expected between July and August, with swimmer's plots to show early durability but median DOR likely immature.

• The pivotal dose is 2000 mg QD with food, chosen based on exposure-response, safety, and food effect data.

• The study is designed to allow for either an ovarian-only or tumor-agnostic NDA filing, depending on data maturity.

• Target ORR for regulatory approval is 30% at six months, with 12% as the standard of care benchmark for ovarian.

• FDA interactions have been stable and positive, with no significant team changes.

Clinical and commercial considerations

• Prior data showed responses across multiple histologies, supporting a tumor-agnostic approach.

• Ovarian cancer is overrepresented due to higher mutation frequency and unmet need.

• Commercialization options are open, with U.S. prioritized and European engagement ongoing at the national level.

• Patient identification is facilitated by broad NGS adoption; tolerability profile is favorable.

• Cash reserves of $166 million are expected to fund operations through 2026 and NDA submission.