Genmab, Janssen Link In Daratumumab Phase 3 Study In Myeloma

Genmab reported that it has partnered with Janssen Biotech and French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) to conduct a Phase 3 trial of daratumumab in frontline multiple myeloma.

Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity under development for the treatment of multiple myeloma. The drug works by zeroing in on the CD38 molecule prominently expressed on the surface of multiple myeloma cells. As CD38 is also found on the surface of other cancer cells, daratumumab may also possess potential to treat chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia, acute myeloid leukemia (AML), and mantle cell lymphoma (MCL), among others. Genmab recently presented data for daratumumab and ofatumumab at the recent American Society of Hematology Annual Meeting (ASH).

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to daratumumab for the treatment of multiple myeloma. In August 2012, Janssen Biotech acquired the global license to daratumumab from Genmab.

The open label, randomized, multicenter Phase 3 study (MMY3006) will investigate daratumumab plus bortezomib, thalidomide, and dexamethasone (VTD) compared to VTD alone as front line treatment for patients who are eligible for stem cell transplantation (SCT). An estimated 1,000 patients with treatment-naïve symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant will be enrolled. The primary endpoint of the trial’s first stage will be the number of patients that achieve stringent Complete Response (sCR) while the second stage’s primary endpoint will be progression free survival (PFS).

“The daratumumab development plan is progressing at a very fast pace and we are very pleased to announce yet another Phase 3 study. The expansive development program covers different stages of multiple myeloma, and this will be the third Phase 3 study to enroll patients newly diagnosed with the disease,” said Dr. Jan van de Winkel, CEO of Genmab.

The company said it plans to begin the new Phase 3 study next year together with two other Phase 3 front line studies.