Nordic Life Science 1
TOP STORIES BUSINESS NSCLC BerGenBio announces Ph
ase II results Martin Olin, CEO, BerGenBio The company has announced topline data from BGBC008, a phase 2 trial evaluating its lead compound bemcentinibin combination with MSD’s anti-PD-1 therapy pembrolizumab in 2L+ Non-Small Cell Lung Cancer (NSCLC) patients. A L Z H E I MER ’ S DI S E A S E FDA approves LEQEMBI under the accelerated approval pathway THE ACCELERATED APPROVAL is based on Phase 2b data in early Alzheimer’s disease (AD) patients which demonstrated that LEQEMBI reduced the accumulation of amyloid beta plaque in the brain. Using the recently published data from the large global confirmatory phase 3 clinical trial, Clarity AD, Eisai will work quickly to file a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. The approval of lecanemab-irmb by the FDA entitles BioArctic to a milestone payment of 25 million EUR from Eisai. THE OPEN-LABEL MULTIcenter, single arm, multi-cohort, international trial enrolled 90 evaluable patients with disease progression at study entry, who had received at least one prior line of chemotherapy, immunotherapy, or the combination. A clinically meaningful survival benefit and evidence of disease control was demonstrated regardless of prior therapy, providing a mOS of 13.0 months, mPFS of 6.2 months, DCR of 51.1% and ORR of 11.1%. “Treatment with the com2.23 MILLION EUR ... ... has been secured by Valo Therapeutics from the European Innovation Council (EIC) for a project to progress the company’s PeptiCHIP technology. 12 | NORDICLIFESCIENCE.ORG bination demonstrated long survival benefit and sustained disease control, particularly in patients with AXL TPS > 5, substantiating the relevance of AXL as a target and bemcentinib’s selective inhibition capabilities in NSCLC. Notably, the survival benefit was observed regardless of PD-L1 status. The data support our ongoing phase 1b/2a trial in 1L STK11m NSCLC patients, of whom approximately 80% have AXL expression," says Martin Olin, CEO, BerGenBio.