PMV Pharmaceuticals (PMVP) TD Cowen 46th Annual Health Care Conference summary

Key clinical insights

• Lead candidate rezatapopt targets the TP53 Y220C mutation, previously considered undruggable, and shows strong efficacy in heavily pretreated ovarian cancer patients, with a 46% overall response rate (ORR) and median duration of response (DOR) of 8 months in this group.

• Across all tumor types, the interim phase 2 analysis shows a 34% ORR and 7.6-month median DOR, with rapid median time to response of 1.3 months.

• Safety profile is favorable, with most adverse events being grade 1 or 2 and only 4 patients discontinuing due to treatment-related events; GI side effects have decreased with administration alongside food.

• ctDNA analysis demonstrates a 91% reduction in TP53 Y220C variant allele frequency, supporting on-target activity.

• 40% of patients remain on treatment at data cutoff, indicating ongoing benefit.

Regulatory and development strategy

• NDA submission for platinum-resistant/refractory ovarian cancer is planned for Q1 2027, with a potential US launch by end of 2027 and pursuit of accelerated approval.

• Ongoing engagement with FDA, which has been supportive of the registrational path; further regulatory updates and data are expected in the second half of 2024.

• The pivotal phase 2 PYNNACLE study is enrolling globally, with 70 sites activated and a balanced US/ex-US patient split.

• The study design includes 5 cohorts (ovarian, lung, breast, endometrial, other solid tumors), focusing on biomarker-selected, KRAS wild-type patients.

• Post-approval requirements are being addressed through the current trial design, aiming for full approval after accelerated approval.

Commercial and market outlook

• Addressable US market for second-line plus ovarian cancer is estimated at $350–$420 million, with global potential of $520–$630 million.

• Patient identification is facilitated by widespread NGS panel coverage and high rates of mutational testing in ovarian cancer.

• Commercialization may be pursued independently or via partnership, with flexibility depending on market dynamics.

• Expansion beyond ovarian cancer is planned, including label expansion and combination studies in other tumor types and hematologic malignancies.

• Ongoing education and outreach aim to increase awareness and adoption among clinicians and patients.