The FDA granted Fast Track designation to bemcentinib when combined with an anti-PD-L1 agent for patients with STK11 altered advanced/metastatic non-small cell lung cancer without actionable mutations, according to a press release from the manufacturer.

Bemcentinib is a novel, selective AXL inhibitor. In pre-clinical NSCLC models bemcentinib resulted in more tumor-associated T-cells and restored response to anti-PD-1 checkpoint inhibition.

An ongoing phase 2 study evaluating bemcentinib plus pembrolizumab in advanced NSCLC showed, of the 3 patients with the STK11/LKB1 mutations, all had objective clinical response and showed clinical benefit in response to the combination. 

“It has been reported that patients harboring STK11 mutations represents up to 20% of the total NSCLC patient population, representing a large, identifiable subgroup of patients who may benefit from treatment with an AXL inhibitor such as bemcentinib,” Martin Olin, CEO of BerGenBio, said in the release.