Ideaya and Pfizer expand clinical trial collaboration and supply agreements

Ideaya Biosciences, Inc yesterday announced that it has entered into additional clinical trial collaboration and supply agreements with Pfizer Inc to support further evaluation of darovasertib and crizotinib combination therapy in a phase-II potential registration-enabling clinical trial in patients with Metastatic Uveal Melanoma (MUM) and in a phase-I clinical trial in patients with cMET-driven tumours, such as hepatocellular carcinoma (HCC) and/or Non-Small Cell Lung Cancer (NSCLC), Ideaya Biosciences notified in a statement.

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-I/II clinical trial, pursuant to a clinical trial collaboration and supply agreement with Pfizer, the statement said.

“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, MD, Vice President and Head, Clinical Oncology and Medical Affairs, Ideaya Biosciences, in the statement.

“The clinical efficacy of the combination therapy in MUM patients provides proof of concept for potential expansion opportunities in other cMET-driven tumours. We believe that the darovasertib and crizotinib combination therapy can potentially improve on the current standard of care treatment paradigms, for example in HCC, where response rates are modest,” added Michael White, PhD, Senior Vice President and Chief Scientific Officer, Ideaya Biosciences.

Ideaya is targetting a clinical data update for its phase-I/II 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), concluded the statement.