Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 30

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 30
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 duration of response (“mDoR”) was estimated to be 12 months, while the mDoR among patients achieving a CR was not reached, with 89% still in CR at nine months. The safety profile of epcoritamab was manageable and consistent with previous findings. The treatment emergent adverse events (”TEAEs”) occurred during the first 12 weeks of treatment and resolved. The most common TEAEs of any grade (greater than or equal to 15%) included cytokine release syndrome (“CRS”) (49.7%), pyrexia (23.6%), fatigue (22.9%), neutropenia (21.7%), diarrhea (20.4%), injection site reaction (19.7%), nausea (19.7%), and anemia (17.8%). The most common Grade 3 or 4 TEAEs (greater than or equal to 5%) included neutropenia (14.6%), anemia (10.2%), neutrophil count decrease (6.4%), and thrombocytopenia (5.7%). The observed Grade 3 CRS was low (2.5%). No Grade 4/5 CRS was observed. 
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R/R FL. Epcoritamab also received accelerated FDA approval in June 2024, as EPKINLY, for the treatment of adults with R/R FL after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial(s). In May 2024, epcoritamab was added to the NCCN Clinical Practice Guidelines in Oncology for “B-cell Lymphomas” (Version 2.2024) for third-line and subsequent therapy for patients with FL as a Category 2A preferred regimen.
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In August 2024, epcoritamab was granted conditional marketing authorization by the European Commission as a monotherapy for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. In March 2024, Genmab submitted a supplemental Japan New Drug Application ("J-NDA") to the MHLW in Japan for the same indication.
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The approvals were supported