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Genmab reports top-line interim results from ofatumumab Period II reading in Roundabout Unfettered B-Cell Lymphoma

Genmab A/S (Copenhagen:GEN) announced today top-line interim results from an beginning Configuration II apart arm inclined brand read of ofatumumab to gauge the treatment of relapsed Diffusive By B-Cell Lymphoma (DLBCL) in patients inappropriate payment or relapsed following a make progress against apartment uproot.

The purpose of the research was to conclude the efficacy of ofatumumab in patients with relapsed DLBCL unqualified in place of remove or relapsed after transplant. The primordial endpoint of the swatting was purpose effect judge (ORR), as definite by way of an Excluding Consider Commission, remaining a six month duration from start of treatment. A comprehensive of 81 patients were treated in the learn about. Ninety-six percent of the patients in the about had received old rituximab therapy. Fifty-four percent of the patients received between two and five one-time courses of rituximab. Thirty-one percent of patients had received a quondam prevail over apartment uproot and the residual 69% were unfit as far as something transplant. The judicious comeback status (ORR) observed at the interim critique was 11% with a median duration of comeback of 6.9 months.

There were no unexpected safeness findings. The most mean adverse events (>10% of patients) occurring in patients treated with ofatumumab were infections (37%), diarrhea (17%), lethargy (15%), secondary edema (15%), neutropenia (14%), abdominal aching (12%), constipation (12%), nausea (12%), pyrexia (11%), anemia (11%) and leukopenia (11%).

"The comeback type observed in this swat points to the insufficiency to bind CD20 agents with cytotoxic chemotherapeutic agents in soldiery discourage investigations of CD20 analysis in such heavily pretreated DLBCL persistent populations," said Prof. Jan van de Winkel, Ph.D., Chief Regulatory Old bill of Genmab.

Source Genmab A/S

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This entry was posted on Wednesday, August 11th, 2010 at 4:54 am and is filed under Drug Trial. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.

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