On January 13, 2020 Genmab A/S (Nasdaq: GMAB) reported that it has reached the first milestone in its collaboration with AbbVie (Press release, Genmab, JAN 13, 2021, View Source [SID1234573956]).. A USD 40 million milestone payment was triggered by the first patient dosed in the Phase 3 study of subcutaneous epcoritamab versus investigator’s choice of chemotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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"We are very pleased that the first Phase 3 study of epcoritamab has been activated at multiple clinical sites and the first cancer patient has been dosed. We look forward to continued rapid progress in this exciting and rapidly broadening development program," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Epcoritamab is being co-developed by Genmab and AbbVie.
The milestone will be reflected in Genmab’s 2021 guidance, which will be published on February 23, 2021.
About the Study
The Phase 3, open-label, randomized study (GCT3013-05, NCT04628494) will include approximately 480 patients with relapsed or refractory DLBCL who failed or are ineligible for autologous stem cell transplant (ASCT). Patients will be randomized to receive either subcutaneous epcoritamab or one of two chemotherapy regimens as per investigator’s choice, either rituximab, gemcitabine and oxaliplatin (R-GemOx) or bendamustine and rituximab (BR). The primary endpoint of the study is overall survival.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.1 CD20 is a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.2,3 Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.