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

Trial progress and enrollment

• Site activation for the pivotal PYNNACLE phase II trial is nearly complete, with enrollment on target and expected 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, driven by enrollment pace and desire for robust data.

• Approximately 40% of interim patients are from the ovarian cancer cohort, reflecting both mutation prevalence and clinical need.

• All five cohorts (ovarian, lung, breast, endometrial, and other) will be represented in the interim data.

• The interim data update is expected between July and August.

Study design, endpoints, and regulatory strategy

• The trial targets patients with Y220C p53 mutations and KRAS wild-type status, using a single-arm design.

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

• The primary efficacy bar is a 30% ORR at six months, with 12% as the standard of care comparator for ovarian cancer.

• NDA submission is planned by the end of next year, likely starting with ovarian cancer but with the option for a tumor-agnostic label depending on data.

• At least 100 patients with safety data are required for filing, with ongoing FDA engagement and stable review teams.

Efficacy, safety, and cohort insights

• Early responses are expected within the first two cycles, with swimmer's plots to be shared at interim, though median DOR will be immature.

• Phase I data showed a median duration of response of seven months across histologies.

• Activity has been observed in multiple tumor types, with ovarian cancer showing the highest mutation frequency and response rates.

• Safety profile is manageable, with GI toxicities and lab abnormalities mostly grade 1 or 2 and reversible.

• Patient identification is facilitated by broad NGS adoption, and the mutation is present on all major panels.