Clinical stage biotechnology company Seattle Genetics, Inc. (SGEN) said Monday that it has stopped its dacetuzumab Phase IIb diffuse large B-cell lymphoma clinical trial based on a determination that the trial would be unlikely to meet its primary endpoint. In its pre-market activity, shares dropped $0.19 or 1.44% to trade at $12.97.
The company has taken the decision on a recommendation by the Independent Data Monitoring Committee following a pre-specified interim analysis conducted on October 2. The company noted that it will no longer provide dacetuzumab to patients enrolled on the trial.
The study, named SeaGen MARINER trial initiated in December 2007, was a randomized, double-blind phase IIb clinical trial of dacetuzumab or placebo in combination with Rituxan plus ifosfamide, carboplatin and etoposide chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma. The primary endpoint of the study was a superior complete response rate in the dacetuzumab combination arm, compared to the placebo combination arm.
The company was developing dacetuzumab under a worldwide collaboration agreement with Genentech, a member of the Roche Group. Clay Siegall, president and chief executive officer of Seattle Genetics said, "In collaboration with Genentech, we will conduct a detailed analysis of data from the SeaGen MARINER trial. In addition, we are continuing four ongoing phase Ib studies of dacetuzumab for non-Hodgkin lymphoma and multiple myeloma." Seattle Genetics added that an oral presentation of the phase Ib clinical trial evaluating dacetuzumab in combination with Rituxan and Gemzar will be made on December 7 at the American Society of Hematology annual meeting in New Orleans, LA.
SGEN closed Friday's regular trading at $13.16 on the Nasdaq.
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