Genmab A/S (GMAB) News & EventsGMABNews & EventsGenmab A/S

Genmab Receives Approval for TEPKINLY in Combination Therapy for Relapsed Follicular Lymphoma

Genmab (GMAB) announced that the European Commission granted marketing authorization for TEPKINLY in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma. The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial that evaluated fixed-duration TEPKINLY + R2 compared to standard of care R2. "Follicular lymphoma is a persistent form of cancer that remains incurable, which means patients need more treatment options. Patients often relapse and experience shorter remissions and have fewer treatment options each time the disease returns," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris Cite University, Hopital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "The results shown in the EPCORE FL-1 trial are clinically meaningful, demonstrating the potential for TEPKINLY + R2 to change the treatment paradigm for patients, offering the chance at a durable response with a chemotherapy-free option." Epcoritamab is being co-developed by Genmab and AbbVie (ABBV) as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab Reports Significant Results from EPCORE DLBCL-4 Trial

Genmab (GMAB) announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of fixed duration epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, and lenalidomide, compared to standard-of-care, rituximab plus gemcitabine plus oxaliplatin, in adult patients with relapsed or refractory diffuse large B-cell lymphoma who received at least one prior line of treatment. Based on topline results, the trial met its primary objective, demonstrating statistically significant and clinically meaningful improvement in progression-free survival. The risk of disease progression and death was reduced by 60% and 56%, based on different censoring rules in the U.S. and outside the U.S., respectively. The safety profile of epcoritamab when administered in combination with lenalidomide was consistent with the previously reported safety profiles of the individual agents. "These topline results add to the growing evidence supporting the versatility of epcoritamab-based combinations, including fixed-duration epcoritamab, across lines of therapy for patients with relapsed or refractory large B-cell lymphoma who received at least one prior treatment," said Jan van de Winkel, CEO of Genmab. "With each new combination and treatment setting, we are building on our vision for epcoritamab as a core therapy across B-cell malignancies. We look forward to engaging with regulatory authorities as we continue to advance this program." Genmab and AbbVie (ABBV) will engage global regulatory authorities. Data will be submitted for presentation at a future medical meeting.