Investigational Acasunlimab (DuoBody® -PD-L1x4-1BB) in Combination with Pembrolizumab Demonstrates Meaningful Clinical Activity in Phase 2 Trial in Patients with Previously Treated Metastatic Non-small Cell Lung Cancer (mNSCLC)
Media Release
COPENHAGEN, Denmark, and MAINZ, Germany; June 1, 2024
Initial data from the ongoing Phase 2 trial showed a 12-month overall survival (OS) rate of 69% and median overall survival (mOS) of 17.5 months in patients with previously treated PD-L1-positive mNSCLC treated with combination of acasunlimab with pembrolizumab every six weeks
Data from this ongoing Phase 2 study to inform the planned pivotal Phase 3 trial, which is expected to start before the end of 2024
Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) today announced initial data from the Phase 2 GCT1046-04 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311, as monotherapy and in combination with pembrolizumab in patients with PDL(1)-positive mNSCLC who had disease progression following one or more prior lines of anti-PD(L)1 containing treatment. The results showed a 12-month overall survival (OS) rate of 69%, a median overall survival (mOS) of 17.5 months, and a 30% overall response rate (ORR); (confirmed ORR 17%) at time of data cut-off in patients treated with the combination of acasunlimab and pembrolizumab every six weeks. The findings were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL and virtually, May 31-June 4, 2024.