Genmab A/S (NASDAQ:GMAB) revealed top-level findings from its Phase 3 EPCORE DLBCL-1 clinical trial evaluating epcoritamab for patients with diffuse large B-cell lymphoma (DLBCL) on Friday. The study assessed how epcoritamab monotherapy compared against investigator-selected chemotherapy regimens consisting of either rituximab combined with gemcitabine and oxaliplatin (R-GemOx) or bendamustine plus rituximab (BR) in individuals with relapsed or refractory DLBCL.
The global trial included 483 participants, all of whom had experienced at least one prior treatment line and were considered unsuitable candidates for high-dose chemotherapy followed by autologous stem cell transplant (HDT-ASCT). The study commenced in January 2021 and continues to enroll and follow patients.
According to the preliminary data, epcoritamab did not significantly improve overall survival (OS), yielding a hazard ratio (HR) of 0.96, a result that failed to meet statistical significance requirements. Despite this, treatment with epcoritamab administered subcutaneously demonstrated a notable enhancement in progression-free survival (PFS) in comparison to chemotherapy alone.
Other beneficial outcomes associated with epcoritamab monotherapy included elevated complete response rates, longer duration of response, and extended intervals before the need for subsequent therapy. Safety results were consistent with the established profile of epcoritamab, with no unexpected adverse events reported.
Genmab indicated that further detailed analyses are underway to better understand the factors influencing outcomes, including consideration of the impacts from the ongoing COVID-19 pandemic and the increasing availability of novel anti-lymphoma treatments that may affect trial performance and interpretation.
The company plans to submit the full trial data for presentation at an upcoming medical congress. Additionally, Genmab, in collaboration with AbbVie Inc. (NYSE:ABBV), intends to engage with regulatory authorities worldwide to discuss the implications of these results and outline subsequent steps.
Looking forward, Genmab expects to report results in 2026 from two other Phase 3 studies examining epcoritamab administered for fixed-duration treatment in DLBCL patients. Epcoritamab has already received regulatory approval under the brand names Epkinly in the United States and Japan, and Tepkinly in the European Union.
Market analysts have responded to the latest data and its implications. William Blair expressed disappointment regarding the trial missing its OS endpoint, highlighting that this outcome has raised investor concerns about the durability of epcoritamab’s accelerated approval for relapsed or refractory DLBCL.
Nevertheless, analyst Matt Phipps pointed to encouraging Phase 2 results combining Epkinly with R-CHOP chemotherapy, providing reassurance ahead of the expected 2026 readout of the frontline EPCORE DLBCL-2 trial, which could support broader drug usage in the largest DLBCL patient segment.
Phipps further noted that Genmab’s pipeline, with several pivotal study readouts anticipated in 2026 for Epkinly, as well as additional therapies like Rina-S and petosemtamab, offers substantial upside potential. For these reasons, he reaffirmed an Outperform rating on the company’s stock.
Regarding regulatory risks, it appears unlikely that epcoritamab would lose its accelerated approval in DLBCL despite the recent Phase 3 results, according to analysts. Supporting this view, Columvi (glofitamab), a bispecific antibody therapy from Roche Holdings AG (OTC:RHHBY), continues to hold accelerated approval status despite receiving a complete response letter from the FDA in connection with its confirmatory trial. Ongoing studies for epcoritamab may eventually provide the confirmatory evidence required to solidify its approval status.
Shares of Genmab were down 2.36% to $31.49 as of Tuesday’s session close, reflecting investor reactions following the data announcement. Market data was sourced from Benzinga Pro at the time of publishing.