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Millennium And Seattle Genetics Initiate Global Phase 3 Clinical Trial Of ADCETRIS® In Previously Untreated Advanced Hodgkin Lymphoma

Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), and Seattle Genetics, Inc. (Nasdaq: SGEN) today announced the initiation of an international phase 3 clinical trial evaluating ADCETRIS (brentuximab vedotin) as part of a frontline combination chemotherapy regimen in patients with previously untreated advanced Hodgkin lymphoma (HL). The trial is being conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received scientific advice from the European Medicines Agency (EMA). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL.

“Millennium is pleased to announce the initiation of the phase 3 trial of ADCETRIS in patients with previously untreated advanced Hodgkin lymphoma. This is a key step in our efforts to explore the potential of this targeted therapy as part of a frontline treatment regimen,” said Karen Ferrante, MD, Chief Medical Officer, Millennium. “The trial is part of our ongoing development program to explore patient populations that may benefit from treatment with ADCETRIS in earlier lines of therapy and in other CD30-expressing malignancies.”

“There have been no new therapies approved for patients with newly diagnosed HL in many decades, representing a significant need to identify additional treatment options in this setting,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer, Seattle Genetics. “We believe through this novel ADCETRIS-containing regimen we have the potential to redefine the treatment of frontline HL. This trial is also an important part of our development plan for ADCETRIS, and may serve as confirmatory to our U.S. accelerated approval in relapsed HL and systemic anaplastic large cell lymphoma.”

Study Design

The randomized, open-label, phase 3 trial will investigate ADCETRIS+AVD 1 versus ABVD 2 as frontline therapy in patients with advanced classical HL. The primary endpoint is modified progression free survival (mPFS) per independent review facility assessment using the Revised Response Criteria for malignant lymphoma. Secondary endpoints include overall survival (OS), complete remission (CR) and safety. The multi-center trial will be conducted in North America, Europe, Latin America and Asia. The study will enroll approximately 1,040 eligible patients (approximately 520 patients per treatment arm) who have histologically-confirmed diagnosis of Stage III or IV classical HL who have not been previously treated with systemic chemotherapy or radiotherapy.

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ADCETRIS (brentuximab vedotin) is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

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