Adcetris brentuximab vedotin: Preliminary Phase II data

Preliminary data from 42 evaluable patients with CD30-undetectable relapsed/refractory DLBCL in an open-label, North American Phase II trial showed that 1.8 mg/kg IV Adcetris every 3 weeks led to an ORR, the primary endpoint, of 31%, including 4 complete remissions and 9 partial remissions. Median PFS was 1.4 months. Median duration of response has not yet been reached in patients with a complete remission and was 1.6 months in patients with a partial remission. Of 35 evaluable patients with baseline and post-baseline assessments, 63% achieved tumor reduction.

Updated data from 48 evaluable patients with CD30-positive DLBCL in the trial showed that Adcetris led to an ORR of 44%, including a 17% complete remission rate. Median PFS for the cohort was 4 months. Data were presented at the American Society of Hematology meeting in San Francisco. This year, Seattle Genetics plans to start a Phase II trial of Adcetris in CD30-positive DLBCL patients who have relapsed following autologous stem cell transplantation (ASCT) or who are ineligible for transplant. ...