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AXL Inhibitor Bemcentinib Receives Fast Track Designation in Combination Therapy for Lung Cancer

By: JNCCN 360 Staff
Posted: Thursday, June 24, 2021

The U.S. Food and Drug Administration (FDA) recently granted Fast Track designation to the AXL inhibitor bemcentinib in combination with an anti–PD-1/L1 agent for patients with AXL-positive, advanced or metastatic non–small cell lung cancer (NSCLC). Bemcentinib is recommended to be taken once per day via an oral capsule.

The FDA’s decision is based on the results of the phase II BGBC008 clinical trial, which was presented at the 2020 World Conference on Lung Cancer Singapore. The combination of bemcentinib and pembrolizumab was reported to be well tolerated and clinically active in patients with checkpoint inhibitor–naive and checkpoint inhibitor–refractory composite AXL-positive NSCLC.

Bemcentinib may also come with a companion biomarker device called Composite AXL, which is intended to help score tumor and immune cells in the tumor microenvironment that are expressed in 50% of patients. Ongoing results have shown improved outcomes in patients treated with bemcentinib. Other endeavors include the creation of a diagnostic test to examine which populations will benefit the most from AXL inhibition.

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