PMV Pharmaceuticals Updated PC14586 Phase 1 Data Demonstrated Anti-Tumor Activity Across Multiple Solid Tumor Types With a TP53 Y220C Mutation - Seite 2

Safety

• Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>20%) being nausea, vomiting and blood creatinine increased, with a low rate of discontinuations due to a TRAE (3%).
• Gastrointestinal toxicity improved when PC14586 was administered with food.

Phase 2 Plans

• A RP2D of 2000 mg once daily was selected based on overall safety, pharmacokinetics (PK), 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.
  

“These updated data from our ongoing Phase 1/2 PYNNACLE clinical trial showed that PC14586, a first-in-class precision oncology investigational therapy, continues to demonstrate clinical benefit in a patient population of high unmet need. The emerging Phase 1 data have guided us in designing our Phase 2 registrational trial to enroll a TP53 Y220C and KRAS wild-type patient population. This represents approximately 90% of patients with TP53 Y220C-positive tumors and the patient population most likely to derive benefit from PC14586,” said Leila Alland, M.D., Chief Medical Officer of PMV Pharma. “We are excited to initiate our registrational Phase 2 trial in early 2024.”

KOL Webinar
PMV will host a KOL webinar via webcast today at 4:00 PM ET to review the data and provide a regulatory update. The event will feature presentations by Aparna Parikh, M.D., M.S., Director of the Global Cancer Care Program at Mass General Hospital Cancer Center, and PYNNACLE Study Investigator, and PMV management.

To register for the event please click here.

Additional PMV Presentations at AACR-NCI-EORTC Conference
The updated PYNNACLE clinical trial data will also be discussed by Dr. Alland during the Chemistry in Cancer Research Town Hall at 6:00 PM ET on Friday, October 13, 2023, and by Dr. Parikh at 10:00 AM ET on Saturday, October 14, 2023.

About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE study is evaluating PC14586 in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial is to determine the maximum tolerated dose (MTD), and Recommended Phase 2 dose (RP2D) of PC14586 when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers will also be assessed. Phase 2 will be an expansion study with the primary objective of evaluating the efficacy of PC14586 at the RP2D in patients with TP53 Y220C advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).