Genmab A/S reports 51% lower progression or death risk in Phase 3 lymphoma trial
The primary IPI 3 to 5 cohort showed a 0.49 hazard ratio, while the partners plan regulatory talks without a stated filing date.
Adrian Kessler
A 51 per cent reduction in the risk of progression or death emerged from a Phase 3 first-line lymphoma trial as Genmab A/S NASDAQGMAB and AbbVie Inc. NYSEABBV reported topline findings on Monday. Their Oct. 5 joint release compared epcoritamab plus R-CHOP with R-CHOP alone in newly diagnosed diffuse large B-cell lymphoma patients with International Prognostic Index scores of 2 to 5.
The result gives the partners a potential first-line use to pursue for EPKINLY, which is approved in specified relapsed or refractory lymphoma settings but not with R-CHOP for newly diagnosed disease. They said they would consult regulators and submit the data for a medical meeting, without naming a filing or presentation date.
Genmab is a Copenhagen antibody drug developer that shares U.S. and Japanese commercial responsibilities for epcoritamab with AbbVie, a large U.S. drugmaker.
Genmab's U.S. depositary receipts closed Oct. 5 at US$38.48, up 10.73 per cent, according to NASDAQGMAB as of 4 p.m. EDT in New York. AbbVie shares ended Oct. 5 at US$265.76, according to NYSEABBV as of 4:01 p.m. EDT.
Primary Analysis Focused on Higher Risk Patients
The registered EPCORE DLBCL-2 study is open-label and randomized, with patients allocated two to one between epcoritamab plus R-CHOP and R-CHOP alone. The experimental group receives six combination cycles followed by two epcoritamab cycles; controls receive six R-CHOP cycles followed by two rituximab cycles.
The primary analysis covered patients with IPI scores of 3 to 5 and yielded a 0.49 hazard ratio, the partners reported. Its 95 per cent confidence interval was 0.35 to 0.69, and p was below 0.0001. The broader IPI 2 to 5 group also recorded a 0.49 hazard ratio. Its 95 per cent confidence interval was 0.36 to 0.67, with p below 0.0001.
The companies described the combination's safety profile as consistent with the individual treatments, but the Oct. 5 release gave no adverse-event rates by arm. It did not disclose the analyzed patient count or median progression-free survival in either group, so the absolute size of the benefit cannot be calculated from the topline.
"These positive topline results suggest that epcoritamab combined with R-CHOP could offer a potential new standard of care in newly diagnosed DLBCL patients," AbbVie vice-president Daejin Abidoye said in the Oct. 5 release.
The independent data monitoring committee recommended unblinding after the first planned interim efficacy analysis, according to the companies. Their release did not report prior FDA feedback on the study design, and the combination remains investigational in the first-line setting.
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Roche Already Markets a First-Line Option
Roche OTCMKTSRHHBY already markets Polivy plus R-CHP for FDA-approved first-line use in specified DLBCL or high-grade B-cell lymphoma patients with IPI scores of at least 2. Roche's POLARIX trial reported a 0.73 hazard ratio against R-CHOP, but the differing populations and regimens prevent a comparison of the two treatments' relative efficacy.
Regeneron Pharmaceuticals, Inc. NASDAQREGN is developing odronextamab, another CD20xCD3 bispecific antibody. Its December 2024 report described results in DLBCL patients whose disease progressed after CAR-T therapy, a later treatment line than the population in the Genmab study.
The iShares Biotechnology ETF NASDAQIBB, a sector benchmark, closed Oct. 2 at US$205.29, down 0.33 per cent, as of 4 p.m. EDT on Nasdaq.
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The ClinicalTrials.gov API record, last posted Sept. 11, lists June 2027 as the trial's estimated primary completion month. The Oct. 5 release gave no date for regulatory talks or a filing.
