ICML 2025 | Safety and efficacy of epcoritamab + R-CHOP in patients with DLBCL & high-risk features

This year in Lugano we also presented updated results of our Phase I/II international study of epcoritamab, which is a CD20xCD3 bispecific antibody, combined with R-CHOP chemoimmunotherapy for the treatment of patients with diffuse large B-cell lymphoma at high risk of treatment failure and that is patients with an IPI score of 3 and above. This is a population of patients that is clearly underserved by R-CHOP. Their five-year survival figures are just around 50% compared to a 75% or higher in patients with lower-risk disease. So clearly an unmet need there. Epcoritamab as a single agent is approved by the US FDA and other regulatory agencies for the treatment of patients with recurrent large cell lymphoma after two or more lines of systemic therapy. So it clearly did make sense to combine it with anthracycline-based chemoimmunotherapy as a frontline treatment. In this particular trial, we enrolled 47 patients at high risk. Half of them had an IPI of four or five, so very high risk disease. Treatment was administered concurrently. Epcoritamab was started on cycle one day one on a step-up dosing schedule and then was given weekly for the first four cycles and then on day one of cycles five and six and then continued to cover a total of one year. R-CHOP was delivered per the standard of care of course. We did see pretty much no safety signals that were concerning or new compared to what one might expect from the separate use of R-CHOP chemotherapy and single agent epcoritamab, cytopenias being one of the most common adverse events, CRS also being expected and certainly not more severe than one might see with the monotherapy use of epcoritamab. But what was really exciting was the response rates in these patients and 87% complete metabolic response rate in a population where you might expect a lower figure than that. And even more so, encouragingly, looking at the two-year progression-free survival, 82%, two-year duration of response of 83%, and most patients were alive at the same time point. So overall, we think this is a very promising treatment option for patients who are otherwise underserved by standard chemoimmunotherapy. And these data supported the currently ongoing EPCORE-DLBCL study that’s comparing in a randomized fashion standard R-CHOP with R-CHOP plus epcoritamab in patients with newly diagnosed diffuse large B-cell lymphoma. The study will read out in the future. We don’t have those results yet, but we’re certainly very hopeful that particularly in the high-risk population, this could be a paradigm-shifting treatment combination.

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