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Dr Dumbrava discusses the rationale and design of the PYNNACLE trial; phase 1 efficacy and safety findings with PC14586 in patients with p53 Y220C–mutated advanced solid tumors; and the next steps for this research.
Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.
OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.
In today’s episode, sponsored by PMV Pharmaceuticals, we had the pleasure of speaking with Ecaterina E. Dumbrava, MD, about the phase 1/2 PYNNACLE trial (NCT04585750) of PC14586 in patients with p53 Y220C–mutated advanced solid tumors. Dr Dumbrava is an assistant professor in the Department of Investigational Cancer Therapeutics in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston.
At the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, investigators presented phase 1 data from PYNNACLE. At a data cutoff of September 5, 2023, data showed that 67 patients included in the safety analysis who were treated with an efficacious dose of the agent, defined as 1150 mg daily and above, had a median age of 63 years (range, 32-84), and patients had received a median of 3 prior lines of therapy (range, 1-9). In this trial, PC14586 elicited an overall response rate per RECIST v1.1 criteria of 38% at the recommended phase 2 dose of 2000 mg daily.
In our exclusive interview, Dr Dumbrava discussed the rationale and design of the PYNNACLE trial; phase 1 efficacy and safety findings with PC14586 in patients with p53 Y220C–mutated advanced solid tumors; and the next steps for this research.
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