Summary: GSK and Genmab announce the initiation of a Phase III study of
ofatumumab in rituximab refractory patients with indolent B-cell non-Hodgkin's
Lymphoma.
London, UK, Copenhagen, Denmark; September 8, 2010 - GlaxoSmithKline (GSK) and
Genmab A/S (OMX: GEN) announced today the start of a Phase III study in patients
with indolent B-cell non-Hodgkin's lymphoma (B-NHL) who did not respond to or
progressed during, or within 6 months of a rituximab containing regimen. Under
the terms of Genmab's collaboration with GlaxoSmithKline (GSK), Genmab will
receive a milestone payment of approximately DKK 116 million (approximately USD
20 million), triggered by the treatment of the first patient in the study.
About the trial
A total of 338 patients in this open label study will be randomized to receive
either ofatumumab in addition to bendamustine or bendamustine alone. The primary
endpoint of the study is progression free survival. Patients in the bendamustine
monotherapy group will have the opportunity to receive ofatumumab if their
lymphoma progresses.
About Indolent B-Cell Non-Hodgkin's Lymphoma
More than one-third of lymphoma patients have indolent B-cell non-Hodgkin's
lymphoma, which includes follicular lymphoma and other typically slow growing
lymphomas which initially respond to treatment but relapse with time.(1)
Indolent B-NHL is defined by expression of the CD20 molecule, which is the
target of monoclonal antibodies such as rituximab and ofatumumab.(2,3)
About ofatumumab
Ofatumumab is a human monoclonal antibody which targets CD20. Ofatumumab is not
approved in any country for indolent B-cell non-Hodgkin's lymphoma (B-NHL).
About Genmab A/S
Genmab is a leading international biotechnology company focused on developing
fully human antibody therapeutics for the potential treatment of cancer.
Genmab's world class discovery and development teams are using cutting-edge
technology to create and develop products to address unmet medical needs. Our
primary goal is to improve the lives of patients who are in urgent need of new
treatment options. For more information on Genmab's products and technology,
visit www.genmab.com.
About GlaxoSmithKline
GlaxoSmithKline, one of the world's leading research-based pharmaceutical and
healthcare companies, is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For company
information, visit GlaxoSmithKline at http://www.gsk.com.
This Stock Exchange Release 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
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“Risk Management” in Genmab's Annual Report, which is available on
www.genmab.com. Genmab does not undertake any obligation to update or revise
forward looking statements in this Stock Exchange Release nor to confirm such
statements in relation to actual results, unless required by law.
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Contact: Helle Husted, Vice President, Investor Relations, T: +45 33 44 77 30,
M: +45 25 27 47 13, E: h.husted@genmab.com
References
1. Surveillance Epidemiology and End Results (SEER) Cancer Statistics Review
1975-2006, National Cancer Institute.
2. McLaughlin, Peter. Mayo Clinic Hematology/Oncology Review: Part 1 Progress
and Promise in the Treatment of Indolent Lymphomas. The Oncologist, June 2002
Vol. 7, No. 3, 217-225.
3. Cheson, Bruce D. Ofatumumab, a Novel Anti-CD20 Monoclonal Antibody for the
Treatment of B-Cell Malignancies. Journal of Clinical Oncology. July 20, 2010
vol.28 no. 21 3525-3530.
Stock Exchange Release no. 31/2010
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GSK and Genmab Announce Start of Ofatumumab Phase III Combination Study in Non-Hodgkin's Lymphoma
| Source: Genmab A/S
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