Brentuximab vedotin: Phase II data
Top-line data from a single-arm, open-label, international Phase II trial in 58 patients with relapsed or refractory ALCL showed that brentuximab vedotin produced an ORR of 86%. The median duration of response has not been reached at a median follow-up of about 6 months. Patients received 1.8 mg/kg IV brentuximab vedotin every 3 weeks for up to 16 total doses. Additional data will be presented at the American Society of Hematology meeting in Orlando in December.
Based on the results, Seattle Genetics said it hopes to seek approval of brentuximab vedotin for the indication in its BLA submission planned for 1H11. Last month, the company said it planned to seek accelerated approval of the compound to treat relapsed or refractory Hodgkin's lymphoma after reporting data from a pivotal Phase II trial. In the trial, brentuximab vedotin produced an ORR of 75%, with a median duration of response of >6 months, in 102 patients who previously received an autologous stem cell transplant (see BioCentury, Oct. 4). ...