Core Insights - Genmab A/S released topline results from the Phase 3 EPCORE DLBCL-1 trial of epcoritamab for diffuse large B-cell lymphoma (DLBCL), comparing it to standard chemotherapy options [1][2]. Study Details - The global study enrolled 483 patients with at least one prior line of therapy who were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT) [2]. - The trial began in January 2021 and is still ongoing [2]. Data Findings - The study showed an overall survival (OS) hazard ratio of 0.96, which did not reach statistical significance [3]. - Epcoritamab monotherapy demonstrated improvements in progression-free survival (PFS), complete response rate, duration of response, and time to next treatment [3]. Safety Profile - Adverse events observed in the study were consistent with the known safety profile of epcoritamab [4]. - Ongoing analysis will consider various factors, including the impact of the COVID-19 pandemic and the availability of new anti-lymphoma therapies [4]. Future Steps - Full trial results will be presented at a future medical meeting, and Genmab will engage with global regulatory authorities for next steps [5]. - Data from two additional Phase 3 trials evaluating fixed-duration epcoritamab for DLBCL is anticipated in 2026 [5]. - Epcoritamab is already approved as Epkinly in the U.S. and Japan, and as Tepkinly in the European Union [5]. Analyst Commentary - Analysts expressed concerns about the EPCORE DLBCL-1 trial's failure to achieve significant OS results, raising questions about the current r/r DLBCL indication's accelerated approval status [6]. - Confidence remains in the upcoming EPCORE DLBCL-2 trial results in 2026, supported by strong Phase 2 results with Epkinly plus R-CHOP [6]. - Analysts believe it is unlikely that Epkinly will lose its accelerated approval status, citing precedents with other drugs [7]. Market Reaction - Genmab shares were down 2.36% at $31.49 at the time of publication [8].