Brentuximab Vedotin (ADCETRIS®)
About Brentuximab Vedotin
Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to the CD30 antigen using Seattle Genetics' proprietary ADC technology. It comprises an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a cytotoxic (cell-killing) agent, monomethyl auristatin E (MMAE). The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in target cell death.
We are developing brentuximab vedotin in collaboration with Takeda Pharmaceutical Company. Under the collaboration, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has commercialization rights in the rest of the world. The companies are funding joint worldwide development costs on a 50:50 basis, except in Japan where Takeda is fully responsible for development costs.
ADCETRIS® (brentuximab vedotin) is approved in more than 55 countries, including the U.S., Canada, Japan and members of the European Union. In August 2015, the U.S. Food and Drug Administration granted approval of ADCETRIS for the treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as autologous hematopoietic stem cell transplantation consolidation. This label expansion represents the third indication for ADCETRIS in the U.S.
We are also conducting a comprehensive clinical development program in more than 30 corporate and investigator-sponsored clinical trials, including three phase 3 studies designed to evaluate the potential of brentuximab vedotin in earlier lines of its approved indications as well as in many additional types of CD30-expressing malignancies, including cutaneous T-cell lymphoma (CTCL), B-cell lymphomas and mature T-cell lymphomas (MTCL).
These phase 3 clinical trials are ongoing:
- Phase 3 ECHELON-1 frontline Hodgkin lymphoma in combination with chemotherapy
- Phase 3 ECHELON-2 frontline CD30-expressing mature T-cell lymphomas in combination with chemotherapy
- Phase 3 ALCANZA trial for relapsed CD30-expressing cutaneous T-cell lymphoma (enrollment complete)