Graspa: Phase II/III data
Top-line data from the open-label, European Phase II/III GRASPIVOTALL trial in 80 children and adults with relapsed or refractory ALL showed that 150 IU/kg Graspa plus chemotherapy met the co-primary endpoints of reducing the incidence of allergic reactions and of increasing the duration of circulating asparaginase activity vs. native L-asparaginase plus chemotherapy. Specifically, 0% of patients who received Graspa plus chemotherapy experienced an allergic reaction vs. 42% of patients who received native L-asparaginase plus chemotherapy (p<0.001). In the induction phase, 1-2 injections of Graspa plus chemotherapy maintained asparaginase levels of >100 IU/l for an average of 20.5 days vs. 9.2 days for <=8 injections of native L-asparaginase plus chemotherapy (p<0.001). At the end of the induction phase, 71.4% of patients who received Graspa plus chemotherapy experienced complete remission vs. 42.3% of patients who received native L-asparaginase plus chemotherapy. Graspa was well tolerated. ...