BerGenBio ASA 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. The open-label, multi-center, single arm, multi-cohort, international phase 2 trial conducted in collaboration with MSD (Merck and Co. Inc.Rahway, NJ, USA), enrolled 90 evaluable patients with disease progression at study entry, who had received at least one prior line of chemotherapy, immunotherapy, or the combination.

Enrolled patients received the combination of bemcentiniband pembrolizumab until disease progression as assessed by investigators. Topline results from the total evaluable population: A clinically meaningful survival benefit and evidence of disease control was demonstrated with bemcentinibin combination with pembrolizumab regardless of prior therapy, providing a median overall survival (mOS) of 13.0 months (95% CI: 10.1, 16.7), median progression free survival (mPFS) of 6.2 months (95% CI: 4.6, 9.8), disease control rate (DCR) of 51.1% (95% CI: 40.3, 61.8) and overall response rate (ORR) of 11.1% (95% CI: 6.2, 18.1). A significant (p-value < 0.05) and clinically meaningful improvement in mOS based on AXL tumor proportion score (TPS) was observed.

Patients with AXL TPS > 5 (46% of evaluable patients) achieved a mOS of 14.8 months (95% CI: 12.4, 29.6) compared to patients with AXL TPS < 5, who achieved a mOS of 9.9 months (95% CI: 6.7, 17.4). In addition, patients with an AXL TPS > 5 had a mPFS of 8.7 months (95% CI: 6.0, 14.8) compared to 4.6 months (95% CI: 2.7, 8.1) for patients with AXL TPS < 5. The ORR for AXL TPS > 5 was 21.9%. The observed mOS was similar regardless of patient PD-L1 status.

Treatment with bemcentinib in combination with pembrolizumab was well-tolerated.