Brentuximab vedotin is an antibody-drug conjugate (ADC) targeted to CD30, which is highly expressed on ALCL cells.
Brentuximab vedotin (SGN-35) Phase II trial, which was initiated in June 2009, is a single-agent, single-arm study evaluating 55 patients with relapsed or refractory systemic ALCL. Patients receive 1.8mg/kg of Brentuximab vedotin every three weeks for up to approximately one year.
The primary endpoint of the study is objective response rate determined by independent review. Secondary endpoints include duration of response, progression-free survival, overall survival and tolerability.
Reportedly, of seven systemic ALCL patients treated with Brentuximab vedotin in Phase I clinical trials, six (86%) achieved a complete remission. Brentuximab vedotin was generally well-tolerated in these studies.
Thomas Reynolds, chief medical officer of Seattle Genetics, said: “This Phase II trial enrolled in less than a year, driven by interest among clinical investigators and the ALCL patient community.
“We anticipate preliminary data from this trial will be available in the second half of 2010, which is expected to guide the next steps towards bringing this ADC to ALCL patients.
“We believe that systemic ALCL may offer an additional registration pathway for Brentuximab vedotin.”
Nancy Simonian, chief medical officer of Millennium, said: “The quick rate of enrollment in this trial attests to the high unmet need for new therapies for patients with ALCL.”