Genmab's Epkinly Combo Meets PFS Endpoint; Epcoritamab Shows Strong Responses in Elderly DLBCL

Genmab's Phase III EPCORE DLBCL-4 trial met its primary endpoint, showing that a combination of fixed-duration Epkinly (epcoritamab) and Bristol Myers Squibb's Revlimid (lenalidomide) significantly improved progression-free survival (PFS) compared with standard-of-care R-GemOx in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of treatment. The risk of disease progression and death was reduced by 60% and 56% based on different censoring rules in the US and outside the US, respectively. The safety profile of the combination was consistent with the previously reported safety profiles of the individual agents.

Based on the Phase III topline data, Genmab and co-developer AbbVie will engage global regulatory authorities, and data will be submitted for presentation at a future medical meeting. The positive readout follows a negative result from the EPCORE DLBCL-1 trial; while that study was the first Phase III trial to show improved PFS in patients with relapsed/refractory DLBCL who received CD3×CD20 T-cell engaging bispecific monotherapy, the overall survival goal did not achieve statistical significance.

At the European Hematology Association (EHA) 2026 Congress in Stockholm, June 11-14, Genmab presented results from two studies evaluating epcoritamab in first-line treatment of elderly patients with newly diagnosed DLBCL who may have limited options due to age or comorbidities. In the Phase 2 EPCORE DLBCL-3 study, fixed-duration epcoritamab monotherapy demonstrated an overall response rate (ORR) of 67% and a complete response (CR) rate of 58% in 66 evaluable patients with a median age of 82.5 years and a median follow-up of 21.9 months. Median time to response was 1.5 months, median PFS was 13.0 months, and median overall survival was not reached. High rates of minimal residual disease (MRD) negativity were observed, with 92% of evaluable responders achieving MRD negativity, typically by Cycle 3 Day 1 and sustained through Cycle 12 Day 1 in most patients. Cytokine release syndrome occurred in 71% of patients and immune effector cell-associated neurotoxicity syndrome in 18%. The full EPCORE DLBCL-3 results were simultaneously published in The Lancet Haematology.

In the Phase 1b/2 EPCORE NHL-2 study (Arm 8), epcoritamab plus rituximab and dose-attenuated cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) demonstrated an ORR of 93% and a CR rate of 86% in 28 patients ineligible for full-dose R-CHOP due to age (≥75 years) or comorbidities (≥65 years with comorbidities). With more than two years of follow-up, the fixed-duration combination achieved sustained MRD negativity and durable remissions.

Genmab also announced that 23 abstracts, including 20 evaluating epcoritamab, will be presented at the 2026 ASCO Annual Meeting in Chicago (May 29-June 2) and at EHA 2026. Oral sessions will feature the first presentation of full results from the Phase 3 EPCORE DLBCL-1 trial comparing epcoritamab monotherapy to investigator's choice chemotherapy in patients with relapsed/refractory large B-cell lymphoma, as well as additional data from the Phase 3 EPCORE FL-1 trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) versus R2 alone in relapsed/refractory follicular lymphoma. Three abstracts will show ongoing clinical trial evaluations of investigational late-stage medicines rinatabart sesutecan and petosemtamab, including phase 3 trials in endometrial and ovarian cancer and a global phase 2 trial of petosemtamab plus pembrolizumab as first-line treatment of PD-L1 high metastatic non-small cell lung cancer.

Separately, Genmab launched a first-in-human Phase 1 trial of GEN1079, an experimental antibody drug given as a concentrated solution, in participants with select advanced malignant solid tumors. The open-label study is designed to evaluate safety, determine the best dose, and look for early signs of benefit; it is listed as recruiting, with initial submission on 28 Jan 2026 and follow-up lasting from about 33 to 67 weeks.

Genmab A/S is a biotech company specializing in antibody-based therapies for cancer and other serious diseases, with shares listed on Nasdaq Copenhagen and American depositary shares trading on Nasdaq under the ticker GMAB. The company collaborates with large pharmaceutical partners, receiving milestone payments as candidates advance and royalties on net sales of marketed products. Epcoritamab is co-developed with AbbVie under a global oncology collaboration.