Overview
Genmab A/S (NASDAQ:GMAB) shares rose 3.4% in after‑hours trading on Monday after the company announced positive topline data from its Phase 3 EPCORE DLBCL‑4 trial.
Trial Details
The EPCORE DLBCL‑4 study evaluated epcoritamab in combination with lenalidomide versus standard‑of‑care therapy in adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) who had received at least one prior line of treatment. The trial is a global, open‑label, multi‑center, randomized Phase 3 study that commenced on 13 August 2024 and remains ongoing. Patients enrolled had previously received at least one systemic antineoplastic regimen that included an anti‑CD20 monoclonal‑antibody‑containing combination chemotherapy.
Efficacy Results
The primary objective was met, with a 60 % reduction in the risk of disease progression or death (hazard ratio 0.40, 95 % confidence interval 0.30 to 0.55). Progression‑free survival was statistically significant and clinically meaningful in favor of the chemotherapy‑free epcoritamab + lenalidomide regimen.
Regulatory and Commercial Outlook
Genmab and AbbVie intend to engage global regulatory authorities regarding the data and will present detailed results at a future medical meeting. Epcoritamab has already received regulatory approval in more than 65 territories under the brand name EPKINLY in the United States and Japan, and TEPKINLY in the European Union. The drug is co‑developed by Genmab and AbbVie, with both companies sharing commercial responsibilities in the United States and Japan, while AbbVie will handle further global commercialization.
Disease Context
Diffuse large B‑cell lymphoma is the most common subtype of non‑Hodgkin lymphoma worldwide, accounting for approximately 25‑30 % of all lymphoma cases. In the United States, roughly 25,000 new DLBCL cases are diagnosed each year.