Brentuximab vedotin: Additional Phase II data

Additional data from a single-arm, open-label, international, pivotal Phase II trial in 102 patients who previously received an autologous stem cell transplant showed that brentuximab vedotin produced complete and partial remission rates of 34% and 40%, respectively, with a median duration of response of 29 weeks. Additionally, 22% of patients achieved stable disease, and tumor reductions were achieved in 94% of patients. Median OS has not been reached, while PFS was 25 weeks. The most common grade 3/4 adverse events were neutropenia, peripheral sensory neuropathy, thrombocytopenia and anemia. Patients received 1.8 mg/kg IV brentuximab vedotin every 3 weeks for up to 16 total doses. The company has an SPA from FDA for the trial. Data were presented at the American Society of Hematology meeting in Orlando. The partners previously reported top-line data from the trial showing that brentuximab vedotin produced an ORR of 75%, with a median duration of response of >6 months (see BioCentury, Oct. 4).

Seattle Genetics plans to submit a BLA to FDA in 1Q11 seeking accelerated approval for brentuximab vedotin to treat relapsed or refractory Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). Takeda's Millennium Pharmaceuticals Inc. subsidiary hopes to submit an MAA to the European Medicines Agency (EMA) for brentuximab vedotin in 1H11. In October, the partners reported data from a pivotal Phase II trial in patients with ALCL showing that brentuximab vedotin produced an ORR of 86% (see BioCentury, Oct. 18). Furthermore, Seattle Genetics plans to implement a limited patient access program for qualified patients with either indication in the U.S. early next year, while the compound will be made available outside the U.S. and Canada through a compassionate use program. ...