PMV Pharma: PC14586 Phase 1 shows 38% ORR at RP2D; registrational Phase 2 planned early 2024

PMV Pharmaceuticals, Inc.

Confirmed ORR 38% (6/16) at RP2D 2000 mg daily in TP53 Y220C/KRAS wild-type patients; median DoR 7 months.
Responses across ovarian, breast, prostate, lung, endometrial cancers; 34% ORR in efficacious dose range (13/38).
Well tolerated: most TRAEs Grade 1-2 (nausea, vomiting, creatinine increase); only 3% discontinuation due to TRAE.
RP2D selected after End of Phase 1 meeting with FDA in Q3 2023; Phase 2 registrational trial to start early 2024.
Study enrolled heavily pretreated patients (median 3 prior lines); no approved therapies targeting p53 currently exist.

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