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FDA Brief: Bemcentinib Combination Given Fast Track Status for STK11-Altered Advanced Lung Cancer

By: JNCCN 360 Staff
Posted: Friday, November 19, 2021

On November 9, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to a first-in-class selective AXL inhibitor bemcentinib in combination with a PD-1/PD-L1 agent for non–small cell lung cancer (NSCLC). Specifically, the treatment is designed for patients with STK11-altered advanced or metastatic NSCLC without actionable mutations. Up to 20% of patients with NSCLC harbor STK11 mutations.

Preclinical mouse models had previously shown that bemcentinib was effective in systemic inhibition of AXL as well as expansion of tumor-associated T cells and restoration of therapeutic response to anti–PD-1 checkpoint inhibition. The FDA’s decision was also based on phase II clinical trial data results. Patients with advanced NSCLC who had STK11/LKB1 mutations were administered bemcentinb and pembrolizumab. Results showed the combination treatment achieved an objective clinical response or clinical benefit for the three patients so treated.



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