Millennium, Seattle commence brentuximab vedotin phase I trial in patients with ALCL

Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: 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 systemic anaplastic large cell lymphoma (ALCL) patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, which is highly expressed in ALCL.

"The objective and complete response rates observed with single-agent brentuximab vedotin in relapsed or refractory systemic ALCL, and the manageable side-effect profile, provide encouraging justification for its investigation in earlier lines of treatment for this aggressive type of non-Hodgkin lymphoma," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "There have been no significant advances for the treatment of front-line systemic ALCL since the introduction of CHOP chemotherapy for aggressive lymphomas decades ago. New approaches to improve upon the outcomes achieved with standard multi-agent chemotherapy regimens in newly diagnosed ALCL patients are needed."

"ALCL is an area of significant unmet need, and the initiation of this study is an important milestone in our investigation of brentuximab vedotin in earlier lines of CD30-positive hematologic malignancies," said Nancy Simonian, M.D., Chief Medical Officer, Millennium.

The phase I dose-escalation trial will evaluate the safety profile, pharmacokinetics and antitumor activity of brentuximab vedotin when administered sequentially or in combination with multi-agent front-line chemotherapy regimens. The study is expected to enroll up to approximately 60 patients at multiple centers in the United States and Europe.