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Seattle Genetics Launches DLBCL Trial with Rituxan

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Seattle Genetics has begun a Phase IIb trial of SGN-40 in combination with Rituxan plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company’s collaboration agreement with Genentech, Inc., Seattle Genetics will receive a $12 million milestone payment for initiating the study.

“This 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,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “We are moving forward with this global trial based on the encouraging safety profile and clinical activity observed in our phase I single-agent trial in patients with DLBCL, together with preclinical data demonstrating enhanced efficacy of SGN-40 when combined with chemotherapy.”

The phase IIb, randomized, double-blind, placebo-controlled clinical trial, named SeaGen MARINER, is expected to enroll approximately 200 relapsed or refractory 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.

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