Genmab A/S announced today that the French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Biotech, Inc. plans to start an additional Phase III study of daratumumab in frontline multiple myeloma. The study (MMY3006) will compare daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTD) to bortezomib, thalidomide and dexamethasone alone as front line treatment for patients who are candidates for stem cell transplantation (SCT). The study is planned to start in Q2 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start towards the end of this year, with the two other Phase III front line studies to start next year. In total today’s news is the fifth daratumumab Phase III study to be announced.
“The daratumumab development plan is progressing at a very fast pace and we are very pleased to announce yet another Phase III study. The expansive development program covers different stages of multiple myeloma, and this will be the third Phase III study to enroll patients newly diagnosed with the disease,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the MMY3006 daratumumab study
This Phase III study is a randomized, open-label, multicenter study and will include approximately 1,000 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients will be randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint of this part of the study is the number of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo a second randomization to either receive daratumumab maintenance treatment for a maximum of 2 years versus no further treatment (observation). The primary endpoint of this part of the study is progression free survival (PFS).
About daratumumab
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
