FDA Grants Fast Track Designation to Bemcentinib for STK11-Mutated Advanced/Metastatic NSCLC

The FDA granted Fast Track Designation to bemcentinib combined with a PD-L1 agent to treat patients with STK11 altered advanced/metastatic non–small cell lung cancer without actionable mutations.

Bemcentinib (BGB324) in combination with a PD-L1 inhibitor received a fast track designation from the FDA for the treatment of patients with STK11-altered advanced/metastatic non–small cell lung cancer (NSCLC) without actionable mutations, according to a press release from the company responsible for the agent, BerGenBio ASA.1

The combination of bemcentinib and pembrolizumab (Keytruda) was examined as part of the phase 2 BGBC008 trial (NCT03184571), wherein 3 patients with STK11/LKB1 mutations exhibited clinical benefit after receiving the combination.

"We are very pleased to receive Fast Track designation from the FDA for the second time this year and look forward to continuing to explore bemcentinib's potential as a treatment option for [patients with] NSCLC,” Martin Olin, chief executive officer at BerGenBio, said in a press release. “It has been reported that patients haboring STK11 mutations represent 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."

Patients who enrolled on the study received 200 mg of bemcentinib per day and 200 mg of pembrolizumab every 3 weeks. The study’s primary end point is to assess the anti-tumor activity of the treatment combination.

Investigators plan to assess 3 cohorts of patients. Cohort A will feature patients who received no more than 1 prior line of platinum-containing chemotherapy and no prior immunotherapy. Cohort B will include patients who received no more than 1 prior anti–PD-L1 monotherapy. Cohort C will be comprised of patients who received no more than 1 prior anti–PD-L1 therapy combined with a platinum-containing chemotherapy.

According to study findings that were presented at the 2020 World Conference on Lung Cancer Singapore, radiologically evaluable patients in cohort A who were composite AXL (cAXL)–positive experienced an overall response rate (ORR) or 33% and a clinical benefit rate (CBR) of 73%.2 Additionally, those who were cAXL-negative had an ORR of 7% and a CBR of 40%. Moreover, cAXL-positive patients in cohort B had an ORR of 33% and a CBR of 73%, and cAXL-negative patients had an ORR of 0% and a CBR of 29%.

The most common treatment-related adverse effects (TRAEs) were alanine aminotransferase (ALT; 33%), increased aspartate aminotransferase (AST; 32%), and diarrhea (32%). Notably, all TRAEs were reportedly mild and reversible, including all cases of treatment-related ALT and AST increase.


  1. BerGenBio receives FDA fast track designation for bemcentinib in STK11-mutated advanced/metastatic non-small lung cancer (NSCLC). News release. BerGenBio ASA. November 9, 2021. Accessed November 9, 2021. https://tinyurl.com/rbvusubw
  2. Krebs MG, Helland Å, Carcereny Costa E, et al. A phase II study of the oral selective AXL inhibitor bemcentinib with pembrolizumab in patients with advanced NSCLC. Presented at the International Association for the Study of Lung Cancer 2020 World Conference on Lung Cancer Singapore; January 28–31, 2021; Virtual. Abstract OA01.07