Genmab Announces Phase III Study of Daratumumab in Relapsed or Refractory Multiple Myeloma
March 05 2014 - 12:47AM
Company Announcement
- First Phase III study of daratumumab
- Patient recruitment to start in the coming
months
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).
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. 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.
Contact: Rachel Curtis Gravesen, Senior Vice
President, Investor Relations & Communications T: +45 33 44 77
20; M: +45 25 12 62 60; E: r.gravesen@genmab.com This Company
Announcement contains forward looking statements. The words
"believe", "expect", "anticipate", "intend" and "plan" and similar
expressions identify forward looking statements. Actual results or
performance may differ materially from any future results or
performance expressed or implied by such statements. The important
factors that could cause our actual results or performance to
differ materially include, among others, risks associated with
pre-clinical and clinical development of products, uncertainties
related to the outcome and conduct of clinical trials including
unforeseen safety issues, uncertainties related to product
manufacturing, the lack of market acceptance of our products, our
inability to manage growth, the competitive environment in relation
to our business area and markets, our inability to attract and
retain suitably qualified personnel, the unenforceability or lack
of protection of our patents and proprietary rights, our
relationships with affiliated entities, changes and developments in
technology which may render our products obsolete, and other
factors. For a further discussion of these risks, please refer to
the risk management sections in Genmab's most recent financial
reports, which are available on www.genmab.com. Genmab does not
undertake any obligation to update or revise forward looking
statements in this Company Announcement nor to confirm such
statements in relation to actual results, unless required by law.
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
Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark