Genmab announced that its partner Janssen Biotech is preparing to launch a Phase 2 trial for daratumumab as treatment for three different types of non-Hodgkin’s lymphomas (NHL), namely diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).
Daratumumab is a human CD38 monoclonal antibody (mAb) that targets the CD38 molecule highly expressed on the surface of multiple myeloma cells, as well as on other cancer cells such as MCL, CLL, acute lymphoblastic leukemia (ALL), and plasma cell leukemia, among others. The company is also considering investigating the drug in these cancers. Daratumumab is currently being developed for multiple myeloma, for which it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
Janssen Biotech gained the exclusive global rights to develop, produce, and market daratumumab from Genmab in August 2012. The firm will conduct the open-label, multicenter, three arm (DLBCL, FL, MCL) Phase 2 study in an estimated 210 patients with relapsed or refractory non-Hodgkin's lymphoma. The trial’s primary endpoint will measure overall response rate. The mid-stage study will also investigate daratumumab’s safety profile in these indications.
Dr. Jan van de Winkel, CEO of Genmab, said, “With this study we are expanding the scope of the daratumumab development program, beyond multiple myeloma, into NHL, another disease area where new treatment options are needed, and where daratumumab has shown anti-tumor activity in pre-clinical disease models.”
The company said it expects the study to begin patient enrollment next year.
Last month, Genmab and Janssen inked a deal to study daratumumab in a late-stage study in frontline multiple myeloma. The companies also partnered with the French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) for the trial. The Phase 3 study will begin next year, along with other late-stage front line studies.