Ideaya Biosciences and Pfizer have signed clinical trial partnership and supply agreements to assess darovasertib and crizotinib combination treatment in two trials.

Darovasertib is an inhibitor of protein kinase C (PKC) while crizotinib is a c-mesenchymal-epithelial transition factor (cMET) inhibitor.

The companies will analyse the combination therapy in a Phase II potential registration-enabling trial that will enrol metastatic uveal melanoma (MUM) patients.

Another Phase I trial will assess darovasertib plus crizotinib in individuals with cMET-driven tumours, such as hepatocellular carcinoma (HCC) and/or non-small cell lung cancer (NSCLC). 

Presently, Ideaya is analysing darovasertib and crizotinib combination in an ongoing Phase I/II clinical trial enrolling individuals with MUM and those with GNAQ or GNA11 mutant skin melanoma.

This Phase I/II trial is being carried out under a clinical trial partnership and supply agreement between Pfizer and Ideaya. 

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By GlobalData

Ideaya anticipates providing results, including tolerability and clinical efficacy, from the Phase I/II trial of the combination therapy in MUM patients in the middle of this year.  

During the same period, the company also intends to seek regulatory advice from the US Food and Drug Administration (FDA) for a potential registration-enabling study design to assess darovasertib plus crizotinib for MUM.

Maturity of data, including necessary interim evaluations of supportive median duration of response and/or median progression-free survival, could impact the reporting of the clinical data and FDA regulatory guidance.

Ideaya Biosciences senior vice-president and chief scientific officer Michael White said: “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 current standard of care treatment paradigms, for example in HCC, where response rates are modest.”

According to initial clinical data reported in December last year, darovasertib plus crizotinib demonstrated to possess strong clinical activity with a manageable side effect profile for MUM.

In April last year, Ideaya dosed the first subject in Phase I trial of IDE397 to treat methylthioadenosine phosphorylase deletion solid tumours.