Mirati Therapeutics’s sitravatinib failed to meet the primary endpoint in a Phase III trial in patients with non-squamous non-small cell lung cancer (NSQ-NSCLC). The San Diego, US-based company reported plans to disclose study data at a future date.

Sitravatinib was investigated in combination with Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) compared to docetaxel. The primary endpoint of the trial measured overall survival (OS) with a time frame of 36 months.

The secondary endpoints of the trial measured the frequency of treatment-emergent adverse events, objective response rate (ORR) and progression-free survival (PFS). Sitravatinib is a small molecule inhibitor of a closely related spectrum of receptor tyrosine kinases (RTKs).

The Phase III trial (NCT03906071) was estimated to enrol 532 participants with second- or third-line advanced NSQ-NSCLC who progressed on or after platinum-based chemotherapy and checkpoint inhibitor therapy, according to the ClinicalTrials.gov registry.

Principal investigators will be given the option to continue treatment in patients who are experiencing clinical benefit and would like to remain on treatment.

Last December, Mirati Therapeutics announced that the company was on track to provide a final analysis from the Phase III trial, based on the results of an interim analysis on overall survival.

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By GlobalData

Mirati Therapeutics formed a clinical collaboration with BMS in 2019. Mirati Therapeutics sponsored the Phase III trial, while BMS provided Opdivo free of cost. Former CEO and current president for Mirati Therapeutics Charles Baum remarked that the trial was expected to result in a new drug application (NDA) for sitravatinib.

Sitravatinib was also investigated in a Phase III trial in combination with tislelizumab compared to docetaxel in participants with locally advanced or metastatic NSCLC. The trial was sponsored by China-based BeiGene. However, the trial status (CTR20211410) was changed to suspended on the Chinese trial registry on 18 May.

Phase II trial results

In 2021, Mirati Therapeutics announced long-term survival results from an exploratory analysis on sitravatinib. The post hoc data analysis showed that sitravatinib demonstrated durable responses and long-term survival in combination with Opdivo in a Phase II trial.

The Phase II trial (NCT02954991) recruited patients with second- or third-line NSQ-NSCLC who experienced clinical benefit on a prior checkpoint inhibitor and subsequent disease progression.

The exploratory analysis showed that the median PFS was 5.7 months and OS was 14.9 months, with 56% and 32% of patients alive at one or two years, respectively. The ORR was 18%, with 3% of patients achieving a complete response rate and 15% of patients achieving a partial response. The median duration of response was 12.8 months.