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FDA Grants Fast Track Designation to Bemcentinib Combo in Advanced NSCLC
On November 9, 2021, the FDA granted Fast Track designation for bemcentinib in combination with an anti-PD-L1 agent for patients with STK11 altered advanced or metastatic non-small cell lung cancer (NSCLC) without actionable mutations.
The novel, selective AXL inhibitor intends to meet severely unmet clinical needs in the NSCLC landscape. Further, frequent Fast Track interactions with the FDA will allow for the potential to reach the market quicker as an approved product.
During pre-clinical NSCLC mouse models harboring STK11 mutations, researchers evaluated sensitivity to PD-L1 blockade in the absence and presence of bemcentinib. Systemic inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated T-cells and restored the therapeutic response to anti-PD-L1 checkpoint inhibition.
Data from a phase 2 trial of bemcentinib and pembrolizumab as a combination treatment in advanced NSCLC showed that 3 of 3 evaluable patients with identified STK11 or LKB1 mutations demonstrated objective clinical response or clinical benefit to the combination of this AXL inhibitor combo.–Alexa Stoia
