On March 14, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that it has entered into additional clinical trial collaboration and supply agreements with Pfizer Inc. (NYSE: PFE) to support further evaluation of darovasertib and crizotinib combination therapy in a Phase 2 potential registration-enabling clinical trial in patients with metastatic uveal melanoma (MUM) and in a Phase 1 clinical trial in patients with cMET-driven tumors, such as hepatocellular carcinoma (HCC) and/or non-small cell lung cancer (NSCLC) (Press release, Ideaya Biosciences, MAR 14, 2022, View Source [SID1234610059]).
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IDEAYA is currently evaluating the combination of darovasertib, a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with metastatic uveal melanoma (MUM) and in patients with GNAQ or GNA11 mutant skin melanoma in an ongoing Phase 1/2 clinical trial, pursuant to a clinical trial collaboration and supply agreement with Pfizer.
"We are pleased to have Pfizer’s support in connection with a potential registrational clinical trial as our clinical data on the darovasertib / crizotinib combination in MUM continues to mature. Our preliminary clinical data on the darovasertib and crizotinib combination in MUM, reported in December 2021, showed robust clinical activity with a manageable side effect profile. We have an opportunity to positively impact the treatment of patients in this high unmet medical need population," said Dr. Matthew Maurer, M.D., Vice President and Head of Clinical Oncology and Medical Affairs at IDEAYA Biosciences.
"The clinical efficacy of the combination therapy in MUM patients provides proof of concept for potential expansion opportunities in other cMET-driven tumors. We believe that the darovasertib and crizotinib combination therapy can potentially improve on current standard of care treatment paradigms, for example in HCC, where response rates are modest," added Michael White, Ph.D., Senior Vice President and Chief Scientific Officer at IDEAYA Biosciences.
IDEAYA is targeting a clinical data update for its Phase 1/2 clinical trial evaluating the darovasertib and crizotinib combination in MUM in mid-year 2022, including tolerability and clinical efficacy. IDEAYA is also planning to seek FDA regulatory guidance for potential registration-enabling trial design to evaluate darovasertib and crizotinib combination in MUM in mid-year 2022. The timing of the clinical data and FDA regulatory guidance may be influenced by data maturity, including for example, appropriate interim assessments of supportive median duration of response (DoR) and/or median progression free survival (mPFS).