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news.Seattle Genetics has initiated a Phase IIb clinical trial of SGN-40 in combination with Rituxan plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma.
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The Phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen Mariner, is expected to enroll approximately 200 relapsed or refractory diffuse large B-cell lymphoma (DLBCL) patients at more than 60 medical centers worldwide. Patients will receive either Rituxan, ifosfamide, carboplatin and etoposide (R-ICE) plus SGN-40 or R-ICE plus placebo. The primary endpoint of the study is complete response rate. Additional endpoints include safety, tolerability, failure-free and overall survival.
Under the terms of the company’s collaboration agreement with Genentech, Seattle Genetics will receive a $12 million milestone payment for initiating the study.
SGN-40 is a humanized monoclonal antibody that targets the CD40 antigen, which is expressed on most B lineage hematologic malignancies including non-Hodgkin’s lymphoma, multiple myeloma and chronic lymphocytic leukemia.
Clay Siegall, president and CEO of Seattle Genetics, said: “This Phase IIb clinical trial will provide key data on the safety and potential efficacy of adding SGN-40 to standard second-line therapy for the treatment of patients with relapsed diffuse large B-cell lymphoma.”