Genmab has discontinued development of acasunlimab, a bispecific antibody that was in mid and late-stage trials for solid tumours, including non-small cell lung cancer (NSCLC).
Genmab remained brief on details, saying the decision was made as part of a “strategic focus on the most value‑creating opportunities” in its pipeline. The pharma company also conducted a “thorough assessment of the evolving competitive landscape”, which resulted in the acasunlimab programme being axed. The pipeline prioritisation move is not expected to impact the company’s full‑year 2025 financial guidance.
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While Genmab stated that the cancer candidate’s clinical profile has been encouraging, the company will instead pivot its focus to other oncology antibodies. This includes Epkinly (epcoritamab), petosemtamab and rinatabart sesutecan (Rina‑S), which are in late-stage trials. The company only gained access to petosemtamab recently via its $8bn acquisition of Merus in September.
Genmab’s CEO Jan van de Winkel said: “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.”
In 2024, Genmab assumed full development and commercialisation rights to acasunlimab after its collaboration partner BioNTech decided not to advance the asset. Acasunlimab is a bispecific antibody designed to produce an anti-tumour response by targeting both PD-L1 and 4-1BB.
Until now, acasunlimab was being evaluated in combination with MSD’s Keytruda (pembrolizumab) for NSCLC teratment 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 (OS) of 17.5 months.
Acasunlimab was also in Phase II development for melanoma and Phase I development for solid tumours.
William Blair analyst Matt Phipps said: “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, with key pivotal readouts for Epkinly, Rina-S, and petosemtamab. With potential for $8bn in combined peak sales for the company’s three lead assets, we see significant upside for Genmab.”
