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IDEAYA, Pfizer To Evaluate Darovasertib- Crizotinib Combination In MUM And Addl CMET-Driven Tumors

IDEAYA Biosciences, Inc. (IDYA), a synthetic lethality focused precision medicine oncology company, announced Monday that it has entered into additional clinical trial collaboration and supply agreements with Pfizer Inc. (PFE).

Under the deal, Pfizer will support further evaluation of darovasertib and crizotinib combination therapy in metastatic uveal melanoma or MUM and additional cMET-Driven tumors.

Darovasertib And Crizotinib Combination will be evaluated in a Phase 2 potential registration-enabling clinical trial in patients with metastatic uveal melanoma or 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).

IDEAYA is currently evaluating the combination of darovasertib, a PKC inhibitor, and crizotinib, a cMET inhibitor, in patients with 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.

The 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.

Michael White, Senior Vice President and Chief Scientific Officer at IDEAYA Biosciences, said, "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."

IDEAYA said it 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.

The company 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.

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