PMV Pharmaceuticals’ PC14586 Phase 1 data demonstrates anti-tumor activity

PMV Pharmaceuticals announced updated Phase 1 results from its ongoing Phase 1/2 PYNNACLE clinical trial that showed PC14586 achieved efficacy in heavily pretreated patients across multiple tumor types and was well tolerated with a favorable safety profile. Results are being presented in a late-breaking poster session today by Alison M. Schram, M.D., Medical Oncologist at Memorial Sloan Kettering Cancer Center and PYNNACLE Study Investigator, at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics taking place in Boston, Massachusetts. Dr. Schram commented, “Patients with a solid tumor harboring a TP53 Y220C mutation are in need of new treatment options, as currently there are no approved therapies targeting p53. The safety and efficacy data presented today demonstrate the potential of PC14586 to address a high unmet need in patients with TP53 Y220C-positive advanced solid tumors.” Study highlights include: Confirmed responses were observed in patients whose tumors were TP53 Y220C and KRAS wild-type in the efficacious dose range, in multiple tumor types including ovarian, breast, prostate, small-cell lung, and endometrial cancer. Median duration of response was seven months. Overall response rate per RECIST version 1.1 was 38% at the Recommended Phase 2 Dose of 2000 mg daily and 34% in the efficacious dose range. A RP2D of 2000 mg once daily was selected based on overall safety, pharmacokinetics, and efficacy in alignment with the U.S. Food and Drug Administration at an End of Phase 1 meeting held in Q3 2023. The planned Phase 2 patient population includes TP53 Y220C and KRAS wild-type patients. PMV plans to initiate a registrational Phase 2 trial in early 2024.