PMV Pharmaceuticals Updated PC14586 Phase 1 Data Demonstrated Anti-Tumor Activity Across Multiple Solid Tumor Types With a TP53 Y220C Mutation

• Updated PC14586 Phase 1 data presented today as a late-breaking poster at 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
• Confirmed responses observed in multiple tumor types including ovarian, breast, prostate, lung, and endometrial cancer with median duration of response of seven months
• Confirmed overall response rate of 38% at Recommended Phase 2 Dose of 2000 mg daily (6/16 evaluable patients) reflective of the planned Phase 2 patient population (TP53 Y220C and KRAS wild-type)
• Company to host KOL webinar at 4:00 PM ET today to review updated PC14586 Phase 1 clinical data

PRINCETON, N.J., Oct. 12, 2023 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today 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:

Patient Characteristics

• As of the September 5, 2023 data cutoff, 67 safety evaluable patients were treated in the efficacious dose range (1150 mg daily and above).
• Median age was 63 years (32-84); 61% of patients were female.
• Median number of prior lines of systemic therapy was three (range: 1-9).
  

Efficacy

• 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 (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.