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Date: 2010-09-08
Phase: III
Anouncement: Launch
Biotech: Genmab (Denmark)
Pharma: GSK (UK)
Product: Ofatumumab + bendamustine
Disease: indolent B-cell non-Hodgkin’s lymphoma
Country:
Other: GSK and Genmab A/have initiated 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.
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.
Under the terms of Genmab and GSK agreement, the treatment of the first patient in this study triggers a milestone payment of approximately DKK 116 million (approximately $ 20 million) (See Summary Table of Agreements).