Partners Seattle Genetics and Millennium are tapping Roche’s Ventana Medical Systems business to develop, manufacture, and commercialize a CD30 companion diagnostic for identifying patients likely to respond to treatment with the lymphoma therapy Adcetris. The antibody drug conjugate (ADC) comprises an anti-CD30 monoclonal antibody attached to the cytotoxic agent monomethyl auristatin E (MMAE), using Seattle Genetics’ linker technology. Adcentris was granted accelerated approval by FDA in 2011 for treating relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL), although a molecular companion diagnostic isn’t currently required for these indications.
However, Adcetris is also in development for a range of other CD30-expressing lymphoma and non-lymphoma malignancies, both as monotherapy and in combination with chemotherapy. As part of their ongoing clinical development program for the drug, Millennium and Seattle are planning two Phase III studies that will incorporate the use of a companion diagnostic. One trial will involve patients with CD30-positive cutaneous T-cell lymphoma (CTCL), and the other patients with CD30-positive mature T-cell lymphomas (MTCL).
“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,” explains Thomas C. Reynolds, M.D., Seattle’s CMO. “The collaboration with Ventana provides an opportunity for development of a diagnostic tool to identify patients who may benefit from Adcetris treatment.”
Seattle and Takeda’s Millennium are developing Adcetris jointly. Under terms of their collaboration Seattle retains U.S. and Canadian commercialization rights to the product, and Takeda has rights to commercialize in the rest of the world. The firms are funding development costs on a 50:50 basis worldwide, except in Japan, where Takeda has sole responsibility for developing Adcetris.