Seattle Genetics, Millennium initiate Phase I Hodgkin Lymphoma drug trial

Seattle Genetics and Millennium Pharmaceuticals, a wholly-owned subsidiary of Takeda Pharmaceutical,

Brentuximab Vedotin is an antibody-drug conjugate (ADC), currently in clinical trials for single-agent clinical trials, a pivotal trial for relapsed and refractory hodgkin lymphoma, and a phase II trial for systemic anaplastic large cell lymphoma. The phase I clinical trial will be evaluating Brentuximab Vedotin in combination with Adriamycin, bleomycin, vinblastine and dacarbazine (ABVD).

The study will evaluate the safety of the proposed combinations along with the pharmacokinetics and the antitumor activity of the drug. Dose-escalation trial will enroll approximately 40 patients from across the US 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 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: the Takeda Oncology Company, under which Seattle Genetics has US and Canadian commercialization rights and Millennium has rights to commercialize Brentuximab Vedotin in the rest of the world. Both firms are jointly funding worldwide development costs for Brentuximab Vedotin on a 50:50 basis.

Thomas Reynolds, chief medical officer of Seattle Genetics, said: "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.

"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."

Nancy Simonian, chief medical officer at Millennium, said: "Millennium is pleased to be collaborating with Seattle Genetics on Brentuximab Vedotin, and we are excited about this molecule's potential in Hodgkin lymphoma. Millennium and Seattle Genetics have a shared goal to develop innovative new medicines where there is an unmet need for patients."