Epcoritamab, Genmab’s bispecific antibody developed with AbbVie, did not achieve the primary overall‑survival (OS) endpoint in the Phase 3 EPCORE DLBCL‑1 study of relapsed or refractory diffuse large B‑cell lymphoma (DLBCL). The trial reported a hazard ratio of 0.74 for progression‑free survival (PFS), indicating a 26 % reduction in the risk of disease progression or death, but the OS hazard ratio of 0.96 did not reach statistical significance, falling short of the 0.80 threshold required for regulatory approval.
The OS miss delays the drug’s potential market entry and weakens Genmab’s projected revenue from its late‑stage portfolio. Analysts had been counting epcoritamab as a key growth engine, and the setback forces the company to reassess the commercial timeline and pricing strategy for the asset. The company’s guidance for 2025 revenue, previously pegged at $3.5‑$3.7 billion, remains unchanged, but the delay may compress the revenue window and affect cash‑flow projections.
CEO Jan van de Winkel said, “The EPCORE DLBCL‑1 trial is the first Phase 3 study evaluating a bispecific antibody monotherapy to demonstrate improvements in PFS in patients with relapsed or refractory DLBCL. While the OS result was not statistically significant, the PFS benefit adds to the growing evidence supporting epcoritamab and informs our next steps with regulators.” The statement signals a cautious but optimistic outlook, emphasizing the need for further data to secure full approval.
Following the announcement, Genmab’s shares fell 4 % to 5 %. Investors focused on the lack of a statistically significant OS benefit, which is a critical endpoint for drug approval and commercial success. The market reaction reflects uncertainty about the drug’s path to full approval and the potential impact on the company’s revenue trajectory.
Genmab’s broader pipeline remains diversified, with other late‑stage assets such as petosemtamab and Rina‑S, and strong royalty income from Darzalex. The company also announced a proposed acquisition of Merus N.V. to strengthen its late‑stage pipeline. The epcoritamab setback underscores the competitive intensity of the oncology market and the importance of achieving definitive clinical endpoints to secure market share and revenue growth.
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