Brentuximab vedotin: Additional Phase II data

Additional data from a single-arm, open-label international Phase II trial in 58 patients with relapsed or refractory ALCL showed that brentuximab vedotin produced complete and partial remission rates of 53% and 33%, respectively. Additionally, 3% of patients had stable disease and tumor reductions were observed in 97% of patients. The most common >=grade 3 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. 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 86% (see BioCentury, Oct. 18).

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 ALCL. Takeda's Millennium Pharmaceuticals Inc. subsidiary hopes to submit an MAA to the European Medicines Agency (EMA) for brentuximab vedotin in 1H11. In September, the partners reported data from a pivotal Phase II trial in patients with relapsed or refractory Hodgkin's lymphoma showing that brentuximab vedotin produced an ORR of 75% (see BioCentury, Oct. 4). 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. ...