Mirati Therapeutics and Bristol-Myers Squibb will work together on evaluating the combination of sitravatinib and nivolumab (OPDIVO), in Mirati’s planned Phase 3 trial in second line non-small cell lung cancer (NSCLC) patients who have progressed following treatment with a platinum-based regimen and a checkpoint inhibitor.
Mirati expects to begin the Phase 3 pivotal trial in the first half of 2019 and will randomize patients to either the combination of sitravatinib with nivolumab or single-agent docetaxel. This interim analysis and the use of a docetaxel control arm follows guidance from Mirati’s FDA end of phase 2 meeting.
The trial will include an interim analysis of overall response rate (ORR) as the basis for potential accelerated approval. The primary endpoint of the final analysis for the Phase 3 clinical trial will be overall survival.
Charles Baum, President and Chief Executive Officer of Mirati said: “The trial is expected to result in a new drug application (NDA) for sitravatinib for the treatment of NSCLC patients whose tumors 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 programs.”