Milestone Announced in Non-Hodgkin’s Lymphoma Phase 2 Study of Daratumumab

Milestone Announced in Non-Hodgkin’s Lymphoma Phase 2 Study of Daratumumab

Genmab A/S announced that it has reached a $5 million milestone in its collaboration with Janssen Biotech, Inc., in the Phase 2 study of Darzalex (daratumumab) as a potential treatment for non-Hodgkin’s lymphoma (NHL).

This milestone payment is the company’s second in the ongoing clinical trial, called LYM2001, and was related to progress seen in the trial’s follicular lymphoma (FL) arm, Genmab announced in a press release. LYM2001 is a three-arm — diffuse large B-cell lymphoma (DLBCL),  mantle cell lymphoma (MCL), and follicular lymphoma — open-label, multicenter study in up to 210 patients with relapsed or refractory (r/r) NHL. Participants will receive daratumumab monotherapy (16 milligram per kilogram), and the study’s primary endpoint is overall response rate. Safety will also be evaluated.

“The daratumumab study in NHL is now underway, and we are very pleased to have achieved milestones for progress in two of the disease areas included in the study, FL and DLBCL,” Genmab’s CEO, Jan van de Winkel, PhD, said. “We remain optimistic about the therapeutic potential of daratumumab in indications outside of multiple myeloma.”

Darzalex (daratumumab) is an intravenous infusion indicated for the treatment of patients with multiple myeloma, and consists of a human IgG1k monoclonal antibody (mAb) that strongly binds to the CD38 molecule, highly expressed on the surface of myeloma cells (NHL, like multiple myeloma, is a malignancy where CD38 is highly expressed). It is the first mAb to be granted U.S. Food and Drug Administration (FDA) approval, and has now been given Orphan Drug designation by the FDA as a potential treatment for DLBCL, MCL and FL.

Janssen Biotech is currently developing daratumumab under an exclusive agreement. Five ongoing Phase 3 clinical trials are testing daratumumab in a relapsed and frontline setting. More studies are either taking place or being planned to assess daratumumab’s potential in other malignant and pre-malignant diseases where cells express CD38, such as smoldering myeloma.

LYM2001 is currently recruiting patients in the U.S., Australia, Europe, and Korea. More information is available through its clinical site (NCT02413489).

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