Seattle Genetics, Millennium: The Takeda Oncology Company and Ventana Medical Systems have formed a collaboration to develop, manufacture and commercialise a molecular companion diagnostic test for Adcetris (brentuximab vedotin) to evaluate CD30 expression levels in tissue specimens.

Adcetris is an antibody drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), leveraging Seattle Genetics’ proprietary technology.

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As part of the ongoing clinical development of adcetris, Millennium and Seattle Genetics are planning two Phase III studies which will use the companion diagnostic assay, one in CD30-positive cutaneous T-cell lymphoma (CTCL) and the other in CD30-positive mature T-cell lymphomas (MTCL).

Under the agreement, Seattle Genetics has US and Canadian commercialisation rights and Takeda has rights to commercialise adcetris in the rest of the world.

Thomas Reynolds, Seattle Genetics chief medical officer, said availability of a CD30 companion diagnostic will bring a personalised, target-based approach to the treatment of cancer and support the ongoing and planned clinical development of adcetris for CD30-positive patients in need.

“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,” Reynolds added.

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“The collaboration with Ventana provides an opportunity for development of a diagnostic tool to identify patients who may benefit from adcetris treatment.”

Millennium chief medical officer Karen Ferrante said they look forward to collaborating with Ventana and Seattle Genetics to develop the new diagnostic tool and expand the ongoing clinical development programme for it in patients with CD30-positive malignancies.

The US Food and Drug Administration had approved adcetris in August 2011 for the treatment of relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL).