Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

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.

Seattle Genetics is conducting an ongoing pivotal trial of brentuximab vedotin for relapsed and refractory Hodgkin lymphoma. The trial is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), and top-line data are planned in the second half of 2010. In addition, the company is conducting an ongoing phase II trial for relapsed and refractory systemic anaplastic large cell lymphoma and a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin therapy. The company also plans to initiate a phase III relapse prevention trial for post-transplant Hodgkin lymphoma patients in the first half of 2010.

Seattle Genetics is developing brentuximab vedotin in collaboration with Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company, under which Seattle Genetics has U.S. and Canadian commercialization rights and Millennium has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and Millennium are jointly funding worldwide development costs for brentuximab vedotin on a 50:50 basis.