Genmab Announces Data From Multiple Clinical Trials Showing Treatment with Fixed-Duration Epcoritamab Led to Remissions in First-Line Diffuse Large B-Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL)

• New two- and three-year EPCORE® NHL-2 follow-up data evaluating epcoritamab in combination with standard of care regimens demonstrate remission in patients with DLBCL and FL
• Latest EPCORE DLBCL-3 trial results show encouraging overall response and complete response rates for epcoritamab monotherapy in newly-diagnosed, elderly patients with DLBCL
• Data presented at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH) reinforce the potential utility of epcoritamab in earlier lines of therapy with a fixed treatment duration

COPENHAGEN, Denmark--(BUSINESS WIRE)-- Genmab A/S (Nasdaq: GMAB) today announced updated results from two ongoing clinical trials evaluating the efficacy and safety of epcoritamab-bysp, a T-cell engaging antibody administered subcutaneously, as a monotherapy and in combination with other standard of care treatments in adult patients with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). Results from two arms of the EPCORE® NHL-2 trial, evaluating first-line, fixed-treatment duration epcoritamab in combination with chemotherapies, demonstrated overall response rates (ORR) of 93% (Arm 8) and 98% (Arm 1) in patients with newly-diagnosed DLBCL, while a third arm (Arm 3) demonstrated a three-year overall survival (OS) rate of 96% in patients with FL following first-line combination treatment.

In EPCORE DLBCL-3, the ORR was 73% in elderly patients with DLBCL treated with first-line, fixed-duration epcoritamab monotherapy who were unable to receive standard anthracycline-based chemotherapy. The study also showed that 54% of patients were progression free and 65% were alive at one year. The results from both studies were presented today in two oral presentations (abstracts 63 and 64) and two poster presentations (abstracts 1955 and 5357) at the 67th Annual Meeting and Exposition of the American Society of Hematology (ASH), in Orlando, Florida.

EPCORE® NHL-2, Arm 8 Results

Two-year follow up from Arm 8 of the EPCORE NHL-2 trial (abstract 64) showed fixed-duration epcoritamab plus rituximab plus dose-attenuated cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) demonstrated an ORR of 93% and complete response (CR) rate of 86% in elderly patients with newly diagnosed DLBCL ineligible for full-dose R-CHOP due to age or comorbidities (n=28). Responses were maintained at two years for an estimated 79% of all responders. Additionally, 20 out of 22 patients who completed the eight cycles of treatment had a CR at the end of treatment and 90% of them remained in CR nearly two years later. Minimal residual disease (MRD) negativity was reported in 20 out of 21 evaluable patients, including clinically relevant sub-groups; this was achieved in 16 patients by the start of cycle 3, and 12 maintained this status through the start of cycle 6.

Treatment-emergent adverse events (TEAEs) were consistent with previous studies evaluating epcoritamab and included Grade ≥3 infection in 32% (n=9) of patients, occurring within the first 6 cycles of treatment in the majority (7/9) of these patients. TEAEs led to epcoritamab discontinuation in 11% (n=3) of patients, including Grade 2 rhinitis, Grade 2 cytokine release syndrome (CRS), and Grade 5 confusional state and cytomegalovirus infection reactivation in a 90-year-old patient with a recent acute cerebrovascular accident.

“Despite an older population of newly diagnosed diffuse large B-cell lymphoma, the outcomes observed in Arm 8 of the EPCORE NHL-2 evaluating fixed-duration epcoritamab plus R-mini-CHOP are encouraging,” said Chan Cheah, M.D., Sir Charles Gairdner Hospital and the University of Western Australia, Nedlands, Australia. “These results, along with those from other arms of the trial, support the potential for combinations of epcoritamab with standard of care treatment across a range of disease settings and patient populations.”

EPCORE® NHL-2; Arm 1 Results

In Arm 1 (abstract 1955), treatment with fixed-duration epcoritamab plus R-CHOP resulted in durable remissions lasting more than three years in most patients with newly diagnosed DLBCL and high International Prognostic Index (IPI) scores, an indicator of poor prognosis (n=47). After a median follow up of 44.2 months (95% CI, 38.9-44.4), the ORR was 98% and the CR rate was 85%. An estimated 74% of CRs were ongoing at three years. High CR rates were observed regardless of IPI score (IPI 3, 86% vs IPI 4-5, 83%). At three years, an estimated 69% of patients remained progression free and 83% were alive; survival outcomes were consistent regardless of IPI score (3 vs 4–5). Efficacy outcomes were also similar across subgroups based on age (≤60 vs >60 years), tumor size (

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