Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that it has discontinued the SeaGen MARINER clinical trial based on a determination that the trial would be unlikely to meet its primary endpoint of superior complete response rate in the dacetuzumab combination arm as compared to the placebo combination arm. The SeaGen MARINER trial was a randomized, double-blind phase IIb clinical trial of dacetuzumab or placebo in combination with Rituxan® (rituximab) plus ifosfamide, carboplatin and etoposide (R-ICE) chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial was closed based upon a recommendation by the Independent Data Monitoring Committee (IDMC) following a pre-specified interim analysis conducted on Friday, October 2, 2009. As a result of the closure, dacetuzumab will no longer be provided to patients enrolled on the trial.
Dacetuzumab is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies, as well as some solid tumors. Seattle Genetics is developing dacetuzumab under a worldwide collaboration agreement with Genentech, a wholly owned member of the Roche Group. An oral presentation of a phase Ib clinical trial evaluating dacetuzumab in combination with Rituxan and Gemzar® (gemcitabine) will be made on December 7, 2009 at the American Society of Hematology annual meeting taking place in New Orleans, LA.