Bemcentinib Earns FDA Fast Track Designation for AXL+ NSCLC

FDA grants fast track designation to bemcentinib in combination with an anti–PD-1/L1 agent for patients with AXL-positive, advanced or metastatic non–small cell lung cancer (NSCLC), announced the agent’s developer BerGenBio ASA.

Bemcentinib is a highly selective AXL inhibitor administered by oral capsule once per day.According to BerGenBio ASA, bemcentinib was designed to target and bind with the intracellular catalytic kinase domain of AXL receptor tyrosine kinase, in turn inhibiting its activity.

“Building on our encouraging clinical and translational data, we are excited to receive Fast Track designation from the FDA for the promising combination of bemcentinib in combination with a checkpoint inhibitor,” Richard Godfrey, chief executive officer for BerGenBio, said in a press release.

AXL is a cell membrane receptor that has been linked to resistance and immune escape by cancer cells which causes a more aggressive form of cancer. It is also linked to suppression of immune response, which creates treatment failure overall. If a patient presents with high AXL expression, it creates a very poor prognosis. Bemcentinib presents a high potential for use as a monotherapy as well as helps to address any unmet medical needs.

BerGenBio also developed Composite AXL (cAXL), which is a biomarker to help score tumor and immune cells in the tumor microenvironment that is highly expressed in 50% of patients. This has showed positive and improved outcomes for those being treated with bemcentinib.

At the recent 2020 World Conference on Lung Cancer (WCLC) Singapore, treatment with the bemcentinib and the PD-1 inhibitor pembrolizumab (Keytruda) in patients with checkpoint inhibitor (CPI)-naïve and CPI-refractory cAXL–positive NSCLC was well tolerated and clinically active, according to results from a phase 2 BGBC008 clinical trial(NCT03185471).

“This regulatory milestone is particularly meaningful for BerGenBio, as it represents the first formal recognition by a regulator of AXL-positive patients as a discernible patient population and serves as further validation of our belief that AXL inhibition has high potential as a cornerstone of cancer combination therapy,” said Godfrey.

Bemcentinib and AXL have also been looked at in the scope of COVID-19. In the treatment of COVID-19 infections, AXL acts as a coreceptor with ACE2 which allows the SARS-CoV-2 virus to enter a host cell. The AXL then leads to suppression of the immune response in their environment. Through trials, it has been confirmed that bemcentinib stops SARS-CoV-2 entry and allows antiviral response. Studies also found that bemcentinib allowed an increase in ventilator-free survival in COVID-19 patients.

While bemcentinib is currently in a phase 2 trial, BerGenBio is also working to create a diagnostic test. This test will focus on which populations will benefit the most from AXL inhibition.

The current desgination will allow BerGenBio ASA to work closely with the FDA and allow it to reach market more quickly. This will also allow the New Drug Application (NDA) to review it in six months instead of 10.

Reference

BerGenBio Receives FDA Fast Track Designation For Bemcentinib / Anti-PD-(L)1Combination In NSCLC USA. News release. BerGenBio ASA. June 8, 2021. Accessed June 15, 2021. https://bit.ly/3cIbwwm