PMV Pharmaceuticals (PMVP) TD Cowen 45th Annual Healthcare Conference summary

Clinical program updates

• Rezatapopt, a first-in-class p53 reactivator, is in a pivotal Phase II trial targeting TP53 Y220C mutant solid tumors, with interim analysis planned mid-2024 including at least 30 patients and 18 weeks of follow-up.

• Phase I showed a 38% overall response rate (ORR) at the recommended Phase II dose, with responses across six tumor types and a favorable safety profile.

• The Phase II basket study enrolls 114 patients in five cohorts, focusing on KRAS wild-type and TP53 Y220C mutations, with ovarian cancer as a primary cohort.

• Study design allows for accelerated approval strategies, with NDA submission targeted for end of 2026 and $183 million in cash to fund operations through this period.

• 90% of 60 targeted global sites are open, using validated local and commercial NGS tests for patient enrollment.

Efficacy and safety insights

• Tumor shrinkage observed in 87% of evaluable patients, with a median time to response of 1.5 months and seven-month durability.

• Most adverse events were Grade I/II, primarily GI-related, mitigated by food, and only 3% discontinued due to treatment-related events.

• KRAS wild-type patients showed greater depth and durability of response, leading to their selection for Phase II.

• Standard of care ORR in target populations is 7–15%, highlighting high unmet need; rezatapopt aims for a 30% ORR and six-month median durability for regulatory approval.

Regulatory and strategic plans

• Interim analysis will guide initial indication, likely ovarian cancer, with potential to expand to tumor-agnostic approval based on data.

• Engaging with FDA and European authorities to align on approval pathways; global and regional partnerships are under consideration.

• Combination study with azacitidine in AML has begun at MD Anderson and MSK, targeting 25–35 patients.