Graspa: Phase II data

An open-label, dose-escalation, French Phase II trial in 30 patients aged 55 and older with newly diagnosed Philadelphia chromosome-negative (Ph-) ALL showed that 2 infusions of Graspa given during standard induction chemotherapy led to target asparagine depletion for >=7 days, a component of the primary endpoint, in 85% of patients receiving the 100 IU/kg dose (n=13) and in 71% of patients receiving the 150 IU/kg dose (n=14). Only 3 patients received 50 IU/kg Graspa due to insufficient serum asparagine depletion. Median EFS was 11.8 months for 100 IU/kg Graspa and 4 months for 150 IU/kg Graspa, while median OS was 15.6 and 9.5 months, respectively. Additionally, 100 IU/kg Graspa produced 1- and 2-year EFS rates of 46% and 23%, respectively, and 1- and 2-year OS rates of 62% and 23%. Furthermore, 150 IU/kg Graspa produced 1-year EFS and OS rates of 29% and 43%, respectively, while 2-year rates were not available. At the end of induction chemotherapy, Graspa led to complete remission in 2 (77%) patients in the 50 IU/kg dose arm, 10 (77%) patients in the 100 IU/kg dose arm and 9 (64%) patients in the 150 IU/kg dose arm. ...