GlaxoSmithKline and Genmab announce start of ofatumumab Phase III combination study in non-Hodgkin’s lymphoma
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 Genmans 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
Issued: London, UK and Copehagen, Denmark
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).
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GlaxoSmithKline Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2009.
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