Seattle Genetics and Millennium, a subsidiary of Takeda Pharmaceutical, have formed a collaboration with Ventana Medical Systems, a member of the Roche Group, through which 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—an ADC designed to release monomethyl auristatin E into CD30-expressing tumor cells—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).

“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, CMO of Seattle Genetics. “Although the identification of CD30 expression and its role in the diagnosis of Hodgkin lymphoma and [systemic anaplastic large call lymphoma] 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.”

CD30 is a member of the tumor necrosis factor receptor (TNFR) family and is a characteristic cell surface receptor for activated T-cells and B-cells, including the malignant cells of Hodgkin lymphoma and systemic anaplastic large call lymphoma. Published literature also reports CD30 expression in other cancers. Seattle Genetics is currently exploring the potential of Adcetris in two phase II clinical trials to further characterize CD30 expression and evaluate antitumor activity of Adcetris. One trial is evaluating patients with non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, peripheral T-cell lymphoma and other less common lymphoma subtypes, while the second trial is evaluating patients with non-lymphoma malignancies, including multiple myeloma, leukemia and solid tumors. Data from both trials are expected to be reported at upcoming medical conferences during 2012. Adcetris is not FDA approved for treatment of the non-Hodgkin lymphomas and non-lymphoma malignancies studied in these trials.

Doug Ward, vice president and general manager of Ventana, said, “We believe that a personalized healthcare approach is particularly relevant for targeted agents such as Adcetris, an antibody-drug conjugate, and this collaboration provides an opportunity to add to our growing pipeline of companion diagnostic tests.”

Adcetris was FDA approved in August 2011 for relapsed Hodgkin lymphoma and systemic anaplastic large call lymphoma, does not currently require a molecular companion diagnostic.