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 promising efficacy in heavily pretreated cancer patients.

• Phase 2 interim data show a 34% overall response rate (ORR) across all cohorts and a 46% ORR in ovarian cancer, with a median duration of response of 8 months in ovarian cancer.

• Responses are consistent across subgroups, including platinum-resistant and refractory ovarian cancer, with rapid median time to response of 1.3 months.

• Safety profile is favorable, with most adverse events being grade 1 or 2 and manageable; food administration has reduced GI side effects.

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

Regulatory and commercialization 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 has been supportive; further regulatory discussions and data updates are expected in H2 2024.

• Commercialization may be pursued independently or via partnership, with a model similar to other recent biotech launches in ovarian cancer.

• Patient identification is facilitated by broad NGS panel coverage and high testing rates in ovarian cancer; no significant barriers to adoption are anticipated.

• US market potential is estimated at $350M–$420M, with global potential up to $630M for second-line plus ovarian cancer.

Expansion and future development

• Label expansion beyond ovarian cancer is planned, with ongoing studies in endometrial, breast, and other solid tumors.

• Investigator-initiated studies are underway in AML/MDS in partnership with MD Anderson, with future plans for combination therapies in both hematologic and solid tumors.

• Preclinical data support combination with bevacizumab, and future combinations with pan-KRAS inhibitors and standard-of-care agents are being explored.

• Enrollment is global and balanced between US and ex-US sites, with 70 sites activated and 120 patients targeted in the ovarian cancer cohort.

• Educational efforts focus on linking TP53 mutation detection to therapeutic action, leveraging established NGS testing practices.