On January 13, 2021 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that it will present an update from its Phase II study of bemcentinib in combination with anti-PD-1 therapy pembrolizumab (BGBC008) in refractory non-small cell lung cancer (NSCLC) patients at an oral presentation at the 2020 World Conference on Lung Cancer Singapore (WCLC) (Press release, BerGenBio, JAN 13, 2021, View Source [SID1234574334]).
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BGBC008 is a Phase II single-arm, two stage study with bemcentinib and
pembrolizumab for previously treated Stage IV NSCLC patients, comprising three cohorts; chemotherapy failed patients not treated with immunotherapies (post-chemo), patients progressing on prior checkpoint inhibitor therapy (post-CPI monotherapy) and platinum-doublet chemotherapy in combination with immunotherapy (post-chemo-CPI).
The primary endpoint of the study was Overall Response Rate with pre-defined criteria to proceed from the first to second stage in each cohort. Secondary endpoints included Disease Control Rate, Progression Free Survival, Overall Survival and safety.
The interim data shows that bemcentinib in combination with pembrolizumab was well-tolerated and shows promising clinical activity in refractory lung cancer. The presentation will provide updated data from Cohort B of the study, assessing the safety and efficacy of bemcentinib in combination with anti-PD-1 therapy pembrolizumab, in refractory NSCLC patients previously treated with a PD-L1 or PD-1 checkpoint inhibitor (CPI) as a monotherapy.
The full abstract can be found on the WCLC website.
Title: A phase II study of the oral selective AXL inhibitor bemcentinib with
pembrolizumab in refractory patients with advanced NSCLC
Presenting Author: Dr. Matthew G. Krebs PhD.
Session/Abstract ID: Immunotherapy (Phase II/III Trials) / # 3647
Date/Time: Friday 29[th] January 2021 at 09.50 Singapore Time / 02.50 CET
The presentation will be available on BerGenBio’s website from 29 January
2021.
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.