GP2013: Interim Ph III ASSIST-FL data

Interim data from the double-blind, international Phase III ASSIST-FL trial in 629 previously untreated patients with advanced follicular lymphoma showed that GP2013 plus cyclophosphamide, vincristine and prednisone met the primary endpoint of equivalence to Rituxan/MabThera rituximab plus cyclophosphamide, vincristine and prednisone in ORR (87.1% vs. 87.5%). Median PFS and OS have not yet been reached. Novartis said GP2013 also showed equivalent safety and pharmacokinetics to Rituxan. The trial includes a 6-month combination treatment portion and a 2-year monotherapy maintenance portion in responders. Data were presented at the American Society of Hematology meeting in San Diego...