Mirati Therapeutics has formed a clinical collaboration with Bristol-Myers Squibb Company to assess sitravatinib in combination with nivolumab (OPDIVO) for the treatment of patients with second-line non-small cell lung cancer (NSCLC).
Mirati will sponsor and fund the clinical trial, while Bristol-Myers Squibb will provide nivolumab free of cost.
The collaboration involves Mirati’s proposed Phase III pivotal trial in second-line NSCLC patients who have progressed after being treated with a platinum-based regimen and a checkpoint inhibitor.
The trial is scheduled to begin in the first half of this year and will see patients randomised to receive either the combination of sitravatinib and nivolumab or single-agent docetaxel.
An interim analysis of overall response rate (ORR) will be included in the trial to obtain accelerated approval.
The primary endpoint of the Phase III trial will be overall survival.
Mirati Therapeutics president and CEO Charles Baum said: “Our Phase II clinical trial of sitravatinib plus nivolumab in patients with checkpoint refractory NSCLC has shown promising activity and a well-tolerated safety profile.
“The trial is expected to result in a new drug application (NDA) for sitravatinib for the treatment of NSCLC patients whose tumours have progressed following treatment with a platinum-containing regimen and a checkpoint inhibitor.
“This collaboration further validates the potential of sitravatinib and allows Mirati to invest in and expand the development of our clinical and pre-clinical programmes.”
Sitravatinib is a spectrum-selective kinase inhibitor that has the ability to inhibit receptor tyrosine kinases (RTKs), such as TAM family receptors, split family receptors, and RET.
Mirati currently owns the global development and commercial rights to sitravatinib outside certain Asian countries, where it is partnered with BeiGene.
The company can also develop the drug programme in combination with other agents.