Mirati's sitravatinib fails Phase III combo trial in lung cancer
24 May 2023
Phase 3ImmunotherapyDrug ApprovalClinical Result
Mirati Therapeutics announced that a Phase III trial evaluating sitravatinib in combination with Bristol Myers Squibb's PD-1 inhibitorPD-1 inhibitor Opdivo (nivolumab) in advanced non-small-cell lung cancer (NSCLC) did not meet its primary endpoint of overall survival (OS). The company said it would share the SAPPHIRE study data at a future time, but provided no other details.
Company shares slid as much as 11% in after-hours trade following the disclosure Wednesday. The SAPPHIRE trial, which got under way in 2019, was comparing sitravatinib plus Opdivo versus docetaxel in up to 532 patients with second- or third-line non-squamous NSCLC who had progressed on prior chemotherapy and immune checkpoint inhibitor treatment.
Previous setback
Last December, following an interim OS analysis, Mirati said the trial would continue to its final analysis. At the time, BMO Capital Markets said the update suggested sitravatinib plus Opdivo was "showing hints of efficacy and time [was perhaps] needed for OS data to mature." However, they noted that sitravatinib represented a "relatively small opportunity" with peak sales of roughly $880 million, compared to $3.1 billion projected for Mirati's KRAS-blocking therapy Krazati (adagrasib). That drug was approved by the FDA late last year for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC following at least one prior systemic therapy. Mirati has also reported disappointing results from a mid-stage trial of sitravatinib plus Opdivo back in 2018.
In its statement Wednesday, the company said principal investigators would be given the option to continue therapy with the combination for patients who are experiencing clinical benefit. "As we move forward, we are optimistic about our…broad and differentiated pipeline of targeted oncology programmes," stated chief medical officer Alan Sandler.
Sitravatinib is a spectrum-selective kinase inhibitor that targets receptor tyrosine kinases (RTKs), including TAM family receptors TYRO3, Axl and Mer; split family receptors VEGFR2 and KIT; and RET. According to Mirati, the drug's "potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumour microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation."
The drug candidate is being also evaluated in combination with checkpoint inhibitors in selected checkpoint inhibitor naïve-patients.
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