Genmab Discontinues Phase III Lung Cancer Bispecific Antibody Acasunlimab to Focus on Late-Stage Pipeline
核心洞察
Genmab has discontinued development of acasunlimab, a bispecific antibody targeting PD-L1 (搜索) and 4-1BB (搜索) that was in Phase III trials for non-small cell lung cancer treatment.
The decision follows a strategic pipeline prioritization and assessment of the competitive landscape, with analysts noting deterioration of overall survival curves in Phase II data.
The company will redirect resources to three late-stage oncology assets including Epkinly, petosemtamab, and Rina-S, which analysts project could generate $8 billion in combined peak sales.
Genmab has discontinued development of acasunlimab, a bispecific antibody that was advancing through mid and late-stage trials for solid tumors, including non-small cell lung cancer (NSCLC). The Danish biotechnology company made the decision as part of a strategic focus on what it considers the most value-creating opportunities in its pipeline.
The company conducted a thorough assessment of the evolving competitive landscape, which ultimately led to the termination of the acasunlimab program. Despite this significant pipeline change, Genmab indicated that the decision is not expected to impact its full-year 2025 financial guidance.
Clinical Development and Mechanism
Acasunlimab is a bispecific antibody designed to produce an anti-tumor response by targeting both PD-L1 (搜索) and 4-1BB (搜索). The drug was being evaluated in combination with MSD's Keytruda (pembrolizumab) for NSCLC treatment in a Phase III trial (NCT06635824). Data from a Phase II trial in this patient population, reported in June 2024, demonstrated a 12-month median overall survival of 17.5 months.
Beyond lung cancer, acasunlimab was also in Phase II development for melanoma and Phase I development for solid tumors. In 2024, Genmab assumed full development and commercialization rights to the asset after its collaboration partner BioNTech decided not to advance the program.
Strategic Refocus on Late-Stage Assets
While Genmab acknowledged that acasunlimab's clinical profile has been encouraging, the company will pivot its focus to other oncology antibodies in late-stage development. These include Epkinly (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S). The company recently gained access to petosemtamab through its $8 billion acquisition of Merus in September.
"Although the data have been encouraging, the compelling opportunities we see in our late-stage pipeline led us to focus our investments where we believe we can deliver the greatest benefit for patients and shareholders," said Genmab CEO Jan van de Winkel.
Analyst Perspective
William Blair analyst Matt Phipps supported the decision, citing recent deterioration of the overall survival curve from the Phase II trial with longer follow-up. "We believe this is the right decision, given recent deterioration of the overall survival curve from the Phase II trial with longer follow-up, and it does not detract from what we view as one of the best opportunities in large-cap biotech going into 2026," Phipps stated.
The analyst highlighted upcoming pivotal readouts for Epkinly, Rina-S, and petosemtamab, projecting potential for $8 billion in combined peak sales for the company's three lead assets. This outlook suggests significant upside potential for Genmab despite the discontinuation of acasunlimab.