Seattle Genetics, Inc. (Nasdaq:SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502), today announced that they have formed a collaboration with Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group. Under the collaboration agreement, Ventana will seek to develop, manufacture and commercialize a molecular companion diagnostic test with the goal of identifying patients who might respond to treatment with ADCETRIS based on CD30 expression levels in their tissue specimens. As part of the ongoing clinical development of ADCETRIS, Millennium and Seattle Genetics are planning two phase III studies that will use the companion diagnostic, one in CD30-positive cutaneous T-cell lymphoma (CTCL) and the other in CD30-positive mature T-cell lymphomas (MTCL).
ADCETRIS was approved by the U.S. Food and Drug Administration in August 2011 for relapsed Hodgkin lymphoma (HL) and systemic anaplastic large call lymphoma (sALCL). A molecular companion diagnostic is not required for the current FDA-approved indications for ADCETRIS.
“Availability of a CD30 companion diagnostic will bring us a step closer to our vision of a more personalized, target-based approach to the treatment of cancer, and supports our broad ongoing and planned clinical development of ADCETRIS for CD30-positive patients in need,” said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. “Although the identification of CD30 expression and its role in the diagnosis of Hodgkin lymphoma and systemic ALCL is well-established, CD30 expression in other malignancies is more heterogeneous. The collaboration with Ventana provides an opportunity for development of a diagnostic tool to identify patients who may benefit from ADCETRIS treatment.”
“Translational medicine research is central to Millennium’s strategic focus of developing innovative, targeted therapies that provide a high benefit to patients,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “We look forward to collaborating with Ventana and Seattle Genetics to develop this new diagnostic tool and expanding the ongoing clinical development program for ADCETRIS in patients with CD30-positive malignancies.”