Millennium, Seattle Genetics commence Phase III trial of Adcetris

4th November 2012 (Last Updated November 4th, 2012 18:30)

Millennium: The Takeda Oncology Company and Seattle Genetics have commenced a Phase III trial designed to evaluate Adcetris for use as a frontline treatment regimen for advanced Hodgkin lymphoma (HL) in patients not previously treated with systemic chemotherapy or radiotherapy.

Hodgkin lymphoma

Millennium: The Takeda Oncology Company and Seattle Genetics have commenced a Phase III trial designed to evaluate Adcetris for use as a frontline treatment regimen for advanced Hodgkin lymphoma (HL) in patients not previously treated with systemic chemotherapy or radiotherapy.

Adcetris (brentuximab vedotin) is an antibody-drug conjugate (ADC) aimed at CD30, prevalent in both HL and systemic anaplastic large cell lymphoma, which has limited expression in healthy tissue.

Millennium chief medical officer Dr Karen Ferrante said the company is pleased to be starting the Phase III trial of Adcetris.

"This is a key step in our efforts to explore the potential of this targeted therapy as part of a frontline treatment regimen," Ferrante said.

"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."

Around 1,040 eligible patients with stage III or IV classical HL will be enrolled in the randomised clinical trial.

Adcetris+AVD versus ABVD will be evaluated as frontline therapy for patients with previously untreated classical HL in the open-label trial.

The primary endpoint is the modified progression free survival (mPFS) per independent review facility assessment based on the revised response criteria for malignant lymphoma.

Overall survival (OS), complete remission (CR) and safety are the secondary end points of the multi-centre trial scheduled to be conducted in North America, Europe, Latin America and Asia.

Seattle Genetics chief medical officer Dr Thomas Reynolds said; "We believe through this novel Adcetris-containing regimen we have the potential to redefine the treatment of frontline HL."


Image: Micrograph of Hodgkin lymphoma, abbreviated HL. Lymph node FNA specimen. Photo: Courtesy of Nephron.