Investigational Acasunlimab Shows Promising Results in Phase 2 Trial for Metastatic Lung Cancer

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 a combination of acasunlimab with pembrolizumab every six weeks. Data from this ongoing Phase 2 study will inform the planned pivotal Phase 3 trial, expected to start before the end of 2024.

Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) announced initial data from the Phase 2 GCT1046-04 trial (NCT05117242) evaluating acasunlimab (DuoBody-PD-L1x4-1BB) in patients with PD-L1-positive mNSCLC who had disease progression following prior anti-PD(L)1 treatment. The combination of acasunlimab and pembrolizumab every six weeks resulted in a 12-month OS rate of 69%, mOS of 17.5 months, and a 30% overall response rate (ORR).

The Phase 2 study randomized a total of 113 patients in three arms, evaluating acasunlimab alone and in combination with pembrolizumab. The combination therapy showed a higher mOS, disease control rate (DCR), and ORR compared to acasunlimab alone. Adverse events were consistent with the safety profiles of the individual drugs, with mainly grade 1 and 2 treatment-related adverse events.

“We are encouraged by the findings of this ongoing Phase 2 study. The initial results of acasunlimab in combination with pembrolizumab suggest a potential meaningful impact on patients with metastatic non-small cell lung cancer,” said Judith Klimovsky, Executive Vice President & Chief Development Officer, Genmab.

“The data of our Phase 2 trial show that the combination of acasunlimab with PDL1-blockade may be a suitable approach in this heavily pre-treated patient population,” said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech.

The GCT1046-04 trial is evaluating the safety and efficacy of acasunlimab in patients with relapsed/refractory mNSCLC after treatment with standard of care therapy containing immune checkpoint inhibitor therapy. Patients with stage IV NSCLC with at least one prior line of systemic therapy containing an anti-PD-1/PD-L1 and a tumor PD-L1 expression in ≥1% of tumor cells are included. The primary endpoint is ORR, with key secondary endpoints including OS, PFS, TTR, DOR, and safety.

NSCLC is the most common type of lung cancer, often diagnosed at an advanced stage with limited treatment options. Acasunlimab is an investigational PD-L1x4-1BB bispecific antibody showing promising results in combination with pembrolizumab. Genmab and BioNTech are collaborating on the development of acasunlimab in multiple clinical trials.

Forward-looking statements in this release highlight the potential of acasunlimab and the ongoing commitment to developing innovative treatments for patients with cancer and other serious diseases. For more information, please visit the respective company websites.