PMV Pharmaceuticals Inc PMVP announced updated Phase 1 results from its ongoing Phase 1/2 PYNNACLE 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 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
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.
The median duration of response was seven months.
The overall response rate (ORR) per RECIST version 1.1 was 38% (6/16 evaluable patients) at the Recommended Phase 2 Dose (RP2D) of 2000 mg daily and 34% (13/38) in the efficacious dose range.
Treatment-related adverse events (TRAEs) were mostly mild or moderate, with the most frequent TRAEs observed being nausea, vomiting, and increased blood creatinine.
Gastrointestinal toxicity improved when PC14586 was administered with food.
A recommended phase 2 dose of 2000 mg once daily was selected based on overall safety, pharmacokinetics (PK), and efficacy in alignment with the FDA at the end of the 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.
Price Action: PMVP shares are down 39.20% at $2.89 on the last check Thursday.
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