Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 31

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 31
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 by results from the FL cohort of the pivotal Phase II EPCORE NHL-1 trial. In June 2023 we announced positive topline results from this cohort. The study cohort included 128 adult patients with R/R FL who received at least two prior lines of systemic therapy. 70.3% of patients were double refractory to an anti-CD20 monoclonal antibody and an alkylating agent. The topline results from this cohort showed an ORR of 82% as confirmed by an independent review committee, which exceeded the protocol prespecified threshold for efficacy. The observed mDoR was not reached. No new safety signals were observed with epcoritamab in this study at the time of analysis. The most common treatment-emergent adverse event was CRS with 66.4% (1.6% grade >2). Aligned with the FDA’s Project Optimus, the optimization part of the trial continued to evaluate alternative step-up dosing regimens to mitigate the risk of CRS; preliminary data on the initial patients enrolled indicate a clinical improvement in CRS rate. The results from this cohort, along with the results from the optimization part of the trial, were presented during the American Society of Hematology (“ASH”) Annual Meeting in December 2023. 
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Ongoing Phase III Trials
Along with our collaboration partner, AbbVie, we are currently evaluating SC epcoritamab for the treatment of B-cell malignancies including DLBCL, FL and CLL in multiple clinical trials. Additional trials, including Phase III trials, are expected. Following are the ongoing Phase III trials:
EPCORE DLBCL-1 was the first Phase III trial of epcoritamab. The purpose of the open label, randomized, multi-center trial is to evaluate the efficacy of epcoritamab compared to investigator’s choice of chemotherapy in patients with R/R DLBCL who have failed or are ineligible for autologous stem cell transplant (“ASCT.”) The trial is fully recruited and currently ongoing.
EPCORE DLBCL-2 is a Phase III randomized, open-label trial to evaluate the safety and efficacy of epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (“R-CHOP”) compared to R-CHOP in patients with newly diagnosed DLBCL. The trial is fully recruited and currently ongoing.
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