- First Phase III study of daratumumab
- Patient recruitment to start in the coming months
COPENHAGEN, Denmark, March 5, 2014 (GLOBE NEWSWIRE) -- Genmab A/S (OMX:GEN) announced today that its partner, Janssen Biotech, Inc. ("Janssen") will start a Phase III study of daratumumab in relapsed or refractory multiple myeloma. The study will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
"The daratumumab development program is progressing very well. We are extremely pleased to be able to announce that this study evaluating daratumumab in combination with a core multiple myeloma treatment regime will initiate patient recruitment in the coming months," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This Phase III study will include approximately 500 patients who have relapsed or refractory multiple myeloma. Patients will be randomized to receive either daratumumab combined with lenalidomide and dexamethasone, or lenalidomide and dexamethasone 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's first marketed antibody, ofatumumab (Arzerra(r)), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of 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(r); the Y-shaped Genmab logo(r); Genmab in combination with the Y-shaped Genmab logo(tm); the DuoBody logo(tm); the HexaBody logo(tm); HuMax(r); HuMax-CD20(r); DuoBody(r); HexaBody(tm) and UniBody(r). Arzerra(r) is a registered trademark of the GSK group of companies.
Company Announcement no. 10
CVR no. 2102 3884
1260 Copenhagen K
Source: Genmab A/S