Copenhagen, Denmark; July 18, 2014 – Genmab A/S (OMX: GEN) announced today that its partner, Janssen Biotech, Inc. (“Janssen”) plans to start a new Phase III study of daratumumab in multiple myeloma. The study (MMY3007) will compare daratumumab in combination with bortezomib, melphalan and prednisone to bortezomib, melphalan and prednisone alone as front line treatment for patients who are not considered candidates for stem cell transplantation (SCT). The study is planned to start in the fourth quarter of 2014.
“We are very pleased to announce the plans for the third Phase III study of daratumumab. The robust development program we designed jointly with Janssen continues moving forward rapidly,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the MMY3007 study
This Phase III study is a randomized, open-label, multicenter study and will include approximately 700 newly diagnosed, chemotherapy naïve multiple myeloma patients ineligible for stem cell transplantation (SCT). Patients will be randomized to receive either daratumumab combined with bortezomib (a unique type of chemotherapy, called a proteasome inhibitor (PI)), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid), or bortezomib, melphalan and prednisone alone. The primary endpoint of the study is progression free survival (PFS).
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. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.
About Genmab A/S
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company currently has one marketed antibody, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications, a clinical pipeline with both late and early stage programs, and an innovative pre-clinical pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, and the HexaBody™ platform which creates effector function enhanced antibodies. Genmab's deep antibody expertise is expected to provide a stream of future product candidates. Partnering of selected innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
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Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo™; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody™ and UniBody®. Arzerra® is a registered trademark of the GSK group of companies.
Company Announcement no. 36
CVR no. 2102 3884
1260 Copenhagen K