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Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Published on February 4, 2010 at 1:12 AM · No Comments

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma. The target for brentuximab vedotin is CD30, which is expressed on these hematologic malignancies. The phase I combination trial will evaluate brentuximab vedotin plus Adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD), a commonly used front-line chemotherapy regimen for Hodgkin lymphoma.

“Millennium and Seattle Genetics have a shared goal to develop innovative new medicines where there is an unmet need for patients.”

“We believe this is an important first step in our investigation of brentuximab vedotin in earlier stage Hodgkin lymphoma patients, towards our ultimate goal of determining the potential of brentuximab vedotin to improve patient outcomes,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “In preclinical studies, including in models with high tumor burden, our data demonstrate that brentuximab vedotin combined with ABVD results in improved antitumor activity compared to ABVD alone, providing a foundation on which to explore this combination in the clinical setting.”

“Millennium is pleased to be collaborating with Seattle Genetics on brentuximab vedotin, and we are excited about this molecule’s potential in Hodgkin lymphoma,” said Nancy Simonian, M.D., Chief Medical Officer at Millennium. “Millennium and Seattle Genetics have a shared goal to develop innovative new medicines where there is an unmet need for patients.”

The phase I dose-escalation trial will evaluate the safety of combining brentuximab vedotin and ABVD, as well as assess pharmacokinetics and the antitumor activity of the combination. The study is expected to enroll approximately 40 patients at multiple centers in the United States and Canada.

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