Investigational Acasunlimab (DuoBody -PD-L1x4-1BB) in Combination with Pembrolizumab Shows Promising Results in Phase 2 Trial for Previously Treated Metastatic Non-small Cell Lung Cancer
COPENHAGEN, Denmark, and MAINZ, Germany, June 1, 2024 - Genmab A/S (Nasdaq: GMAB) and BioNTech SE (Nasdaq: BNTX) have recently announced the preliminary results of their ongoing Phase 2 trial (NCT05117242) evaluating the combination of acasunlimab (DuoBody-PD-L1x4-1BB), a novel bispecific antibody also known as GEN1046/BNT311, and pembrolizumab for the treatment of metastatic non-small cell lung cancer (mNSCLC) patients who have previously failed anti-PD(L)1 therapies.
The data presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago revealed a promising 12-month overall survival (OS) rate of 69%, a median overall survival (mOS) of 17.5 months, and an overall response rate (ORR) of 30% (confirmed ORR 17%) at the time of data cut-off in patients receiving the combination treatment every six weeks.
The study focused on patients with PD-L(1)-positive mNSCLC who experienced disease progression after one or more prior lines of anti-PD(L)1-containing treatment. These patients often face limited treatment options, making the results of this trial particularly significant. The combination therapy demonstrated meaningful clinical activity, showcasing its potential as a new treatment approach for this patient population.
Acasunlimab, an immune checkpoint inhibitor that targets PD-L1, is designed to activate the body’s immune system by blocking the PD-L1 protein on tumor cells. Pembrolizumab, a well-established anti-PD-1 checkpoint inhibitor, works in a similar manner by blocking the receptor PD-1 on immune cells.
The positive outcome of this trial signifies a step forward in the development of immunotherapies for mNSCLC patients. It highlights the importance of combination treatments to overcome treatment resistance and improve patient outcomes. By targeting different checkpoints simultaneously, this approach enhances the immune response against cancer cells, potentially leading to better clinical responses and prolonged survival.
Dr. Jan van de Winkel, CEO of Genmab, expressed his excitement about the promising results. He emphasized the potential impact of acasunlimab in combination with pembrolizumab as a compelling treatment option for mNSCLC patients who have exhausted other therapeutic options.
The ongoing Phase 2 trial aims to further evaluate the safety and efficacy of acasunlimab in combination with pembrolizumab. The researchers also plan to assess the treatment’s impact on the patients’ quality of life, duration of response, and progression-free survival.
While additional data and further analysis are required to confirm the long-term benefits of this combination therapy, the initial findings provide hope for mNSCLC patients who desperately need effective treatment options. With the continued advancements in immunotherapies, the cancer treatment landscape is evolving, bringing new possibilities and renewed hope for better patient outcomes.
Overall, this study sheds light on the potential of acasunlimab in combination with pembrolizumab as a meaningful treatment approach for previously treated metastatic non-small cell lung cancer, offering new avenues for improved patient care, disease management, and extended survival.
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