Epcoritamab combined with standard chemotherapy cut the risk of progression or death by 51% in newly diagnosed patients, the first late-stage win for a bispecific combination in frontline disease. Overall survival, the endpoint that tripped up an earlier trial, has yet to be reported.
Genmab and partner AbbVie said Monday that their drug epcoritamab, added to the standard R-CHOP chemotherapy regimen, met the primary goal of a Phase 3 trial in patients newly diagnosed with diffuse large B-cell lymphoma, the most common aggressive form of the blood cancer.
In the EPCORE DLBCL-2 study, the combination reduced the risk of disease progression or death by 51% compared with R-CHOP alone, a hazard ratio of 0.49 with a 95% confidence interval of 0.36 to 0.67. The result was highly statistically significant. Safety was consistent with the known profiles of each treatment, and the companies plan to discuss the data with regulators worldwide.
The results "have the potential to reshape the frontline treatment landscape," Genmab Chief Executive Jan van de Winkel said.
The companies describe it as the first Phase 3 progression-free survival win for a bispecific antibody combination in frontline DLBCL. The trial enrolled patients at intermediate to high risk, with International Prognostic Index scores of 2 to 5.
The market reaction
Genmab's U.S.-listed shares closed up 10.73% at $38.48 on Monday. The stock opened only about 1% higher, and the announcement came at 2:49 p.m. Eastern, so the bulk of the gain came after the release. On a market value of about $23.6 billion, the move added roughly $2.3 billion. In early Copenhagen trading on Tuesday, Genmab rose 7.95% to 2,566 Danish kroner, its highest level in three years and the top performer in Europe's benchmark STOXX 600. AbbVie rose 1.12% to $265.76.
The gap between those reactions is telling. For Genmab, epcoritamab is a central asset. For AbbVie, a far larger company, it is one product among many.
Why the survival data matter
Investors have reason for caution. A separate Phase 3 trial, EPCORE DLBCL-1, which tested epcoritamab alone in patients whose disease had relapsed, missed its sole U.S. primary endpoint of overall survival in July. Another study pairing the drug with lenalidomide in relapsed patients met its progression-free survival goal in June.
Monday's release gave no absolute progression-free survival rates, no subgroup results and no overall survival figures. Delaying progression is meaningful, but regulators and physicians will want to see whether longer remission translates into longer life before rewriting first-line treatment for a disease where R-CHOP already cures many patients.
Implications for competitors
The result raises the competitive stakes for other CD20xCD3 bispecifics, including Roche's glofitamab and mosunetuzumab, which are pursuing similar ground. The decisive next step is a full data presentation at a medical meeting. If the survival curves separate as clearly as the progression curves did, Monday's rally will look conservative. If they do not, the July miss will return to the center of the debate.