Erytech reports positive Phase III results from Graspa study in acute lymphoblastic leukemia

French firm Erytech Pharma (Euronext: ERYP) and Italian drugmaker Recordati (RC: MI) have reported positive Phase III results from its study of Graspa in acute lymphoblastic leukemia.

Compared to native L-asparaginase, Graspa gave statistically significant reduction of allergic reactions and statistically significant increase in the duration of asparaginase activity. The study also shows favorable results in patients with prior allergies to L-asparaginase.

The study was a controlled, multicenter Phase II/III trial in 80 children and adults suffering from relapsing or refractory acute lymphoblastic leukemia. The trial had three strands, the first two comparing Graspa to native E. Coli L-asparaginase, both in combination with standard chemotherapy in a 1-to-1 randomization in patients without prior allergies to L-asparaginase. The third arm is an open-label assessment of Graspa for patients who have experienced allergic reactions related to asparaginase in their first line treatment.