FDA grants fast track designation to bemcentinib for advanced NSCLC
The FDA granted fast track designation to bemcentinib for treatment of certain patients with non-small cell lung cancer.
The designation applies to use of the agent in combination with an anti-PD-1 therapy for individuals with STK11-altered advanced or metastatic NSCLC who have no actionable mutations.
Bemcentinib (BerGenBio) is a selective AXL inhibitor.
Preclinical research of the agent in NSCLC mouse models harboring STK11 mutations showed bemcentinib led to expansion of tumor-associated T cells and restored therapeutic response to anti-PD-1 checkpoint inhibition, according to a BerGenBio-issued press release.
Data from a phase 2 study in advanced NSCLC showed all three evaluable patients with identified STK11/LKB1 mutations achieved objective clinical response or clinical benefit to the combination of bemcentinib and pembrolizumab (Keytruda, Merck), an anti-PD-1 antibody.
An estimated 20% of patients with NSCLC harbor STK11 mutations, according to the release.
“[This represents] 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.