A new treatment group within the PYNNACLE clinical trial is set to evaluate a novel drug plus Keytruda in patients with p53 Y220C-mutant locally advanced or metastatic solid tumors.
A separate group of patients within the ongoing phase 1/2 PYNNACLE clinical trial will analyze the efficacy of the novel drug PC14586 with Keytruda (pembrolizumab), an immunotherapy agent, according to PMV Pharmaceuticals, the manufacturer of PC14586.
PYNNACLE is an ongoing clinical trial evaluating PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. Now, researchers plan on enrolling approximately 36 more patients into the combination group of the trial, which will assess the safety, tolerability, movement of the drugs throughout the body and efficacy of PC14586 plus Keytruda.
“Building upon the preliminary efficacy observed with PC14586 as monotherapy that was presented at (the American Society of Clinical Oncology Annual Meeting) in June of 2022, we look forward to evaluating the potential of combining PC14586 with Keytruda in a clinical study in collaboration with Merck (the manufacturer of Keytruda),” said Dr. Leila Alland, chief medical officer of PMV Pharma, in a press release.
PC1456 works by binding to p53 Y220, a gene that plays a role in cell division and death. When this gene is mutated, it can lead to the growth of cancer cells. PC1456 normalizes the mutation in p53, thereby allowing it to suppress tumors.
When given alongside Keytruda, the two-drug combination had anti-tumor properties and extended survival times in mice with p53 Y220-mutant advanced cancers, according to preclinical findings that were presented at the American Association of Cancer Research Annual Meeting 2022.
In October 2020, the Food and Drug Administration (FDA) granted a fast track designation to PC14586 for the treatment of metastatic or locally advanced solid tumors with P53 Y220C mutations. In doing so, the agency is helping to facilitate the development and speed up the review of the therapy which, if approved, will fill an unmet medical need.
“Our tumor-agnostic study provides compelling scientific rationale for exploring PC14586 in combination with KEYTRUDA in an effort to improve outcomes for more patients. We are excited to be collaborating with Merck on this study,” Alland said.
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