Phase 2 trial of brentuximab vedotin for the treatment of anaplastic large cell lymphoma (ALCL)

Seattle Genetics and Millennium, a wholly owned subsidiary of Takeda, announced results from its Phase 2 trial of brentuximab vedotin (SGN-35) for the treatment of relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). This single-arm trial assessed efficacy and safety of single-agent brentuximab vedotin in 58 relapsed or refractory ALCL patients. Patients received 1.8mg/kg of brentuximab vedotin every 3 weeks for up to 16 total doses. The primary endpoint of the trial was overall objective response rate as assessed by an independent central review. Eighty-six percent of patients in the trial achieved this primary endpoint.

Brentuximab vedotin is an antibody-drug conjugate (ADC) comprising an anti-CD30 antibody attached by an enzyme cleavable linker to a synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect.

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