Announcement • Jun 15

Genmab Announces Epcoritamab Monotherapy And Epcoritamab-Based Combination Regimens Demonstrate High Response Rates In Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Genmab A/S announced new data from two studies evaluating epcoritamab, a T-cell engaging antibody administered subcutaneously, in the first-line treatment of patients with diffuse large B-cell lymphoma (DLBCL) who may have limited treatment options due to advanced age or multiple health conditions. Results from the Phase 2 EPCORE DLBCL-3 study showed an overall response rate (ORR) of 67% and a complete response (CR) rate of 58% with epcoritamab monotherapy in elderly patients with newly diagnosed DLBCL. In the Phase 1b/2 EPCORE NHL-2 study, epcoritamab plus rituximab plus dose-attenuated cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) demonstrated an ORR of 93% and a CR rate of 86% in elderly patients with newly diagnosed DLBCL. The results from both studies were presented in two poster presentations (abstracts PS2082 and PF1007) at the European Hematology Association (EHA) 2026 Congress held in Stockholm, Sweden, June 11-14. Additionally, the full EPCORE DLBCL-3 results have been simultaneously published in The Lancet Haematology. The Phase 2 EPCORE DLBCL-3 study (abstract PS2082) evaluated the efficacy and safety of fixed-duration epcoritamab monotherapy in newly diagnosed CD20+ large B-cell lymphoma (LBCL) patients ineligible for anthracycline-based chemotherapy due to age (=80 years) or comorbidities (=75 years with comorbidities). Among 66 enrolled patients, the median age was 82.5 years, and all had comorbid conditions (94% with =3 comorbidities). With a median follow-up of 21.9 months, epcoritamab monotherapy demonstrated responses in this population with high unmet medical need. An ORR of 67% and a CR rate of 58% were observed in evaluable patients (n=66). Median time to response was 1.5 months, and median time to CR was 2.2 months. Notably, 11 of 17 patients with a partial response or stable disease at first assessment subsequently achieved a CR. Responses were durable, with median duration of response (DOR) and duration of complete response (DOCR) not reached. At 12 months, an estimated 67% of responses and 73% of CRs remained ongoing. Median progression-free survival (PFS) was 13.0 months, while median overall survival (OS) was not reached; an estimated 43% of patients remained progression-free and 62% were alive at 18 months. 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. The safety profile was consistent with expected rates in this elderly population. Cytokine release syndrome (CRS) occurred in 71% of patients, most commonly during Cycle 1, and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 18%. Infections of any grade occurred in 68% of patients (26% Grade =3), and neutropenia was reported in 16%, with no febrile neutropenia or clinical tumor lysis syndrome observed. Eight Grade 5 TEAEs occurred. Arm 8 of the Phase 1b/2 EPCORE NHL-2 study (abstract PF1007) evaluated epcoritamab plus R-mini-CHOP in 28 newly diagnosed CD20+ DLBCL 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, fixed-duration epcoritamab plus R-mini-CHOP demonstrated high response rates, sustained MRD negativity and durable remissions. An ORR of 93% and a CR rate of 86% were observed. Median DOR, DOCR, PFS, and OS were not reached. At two years, estimated DOR and DOCR rates were 79%, while estimated PFS and OS rates were 76% and 82%, respectively. Rapid and sustained MRD negativity was observed, with 95% of evaluable patients achieving MRD negativity, including high rates in high-risk subgroups. Outcomes compared favorably with historical results for R-mini-CHOP alone. The safety profile was consistent with prior reports and the known safety profiles of epcoritamab and R-mini-CHOP. The most common Grade =3 treatment-emergent adverse events (TEAEs) were neutropenia (54%), serious infections (33%) and anemia (14%). Most Grade =3 serious infections occurred during the first six cycles of treatment with R-mini-CHOP coadministration. TEAEs led to epcoritamab discontinuation in three patients (11%). EPCORE DLBCL-3 (NCT05660967) is an open-label, randomized, global, Phase 2 trial to evaluate the efficacy and safety of epcoritamab as monotherapy or in combination with lenalidomide as first-line therapy for anthracycline-ineligible subjects with diffuse large B-cell lymphoma (DLBCL). This is a 2-stage trial. In Stage 1, eligible patients were randomized to either epcoritamab monotherapy or epcoritamab plus lenalidomide. In Stage 2, additional patients were enrolled to the epcoritamab monotherapy arm. Each treatment cycle is 28 days. Patients will receive a maximum of 12 cycles (up to 1 year) of treatment. The primary objective is to evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide. The primary endpoint is to achieve a complete response rate determined by Lugano criteria. Additional secondary endpoints include overall response rate, duration of response, duration of complete response, rate of minimal residual disease negativity, progression-free survival and overall survival.

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