GSK and Genmab Announce Start of Ofatumumab Phase III Combination Study in Non-Hodgkin's Lymphoma
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.
GlaxoSmithKline (GSK) and Genmab A/S (Copenhagen: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)
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.
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.
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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.
CONTACT: Genmab A/S Helle Husted, Vice President, Investor Relations +45 33 44 77 30 Mobile: +45 25 27 47 13 [email protected]
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