Phase III GRASPALL trial of Graspa in ALL meets endpoints - Erytech

Erytech reports positive Phase III results from its pivotal study with Graspa (human erythrocytes encapsulating L-asparaginase) in Acute Lymphoblastic Leukemia. Analysis of the primary and first secondary efficacy endpoints of the GRASPALL clinical trial with one year follow up shows that the GRASPIVOTALL (GRASPALL2009-06) clinical trial convincingly meets both of its primary endpoints, and that the secondary efficacy endpoints analyzed so far confirm the favorable clinical efficacy profile of Graspa. The study also shows favorable results in patients with prior allergies to L-asparaginase. The GRASPIVOTALL study is a controlled, multicenter Phase II/III trial with 80 children and adults suffering from relapsing or refractory Acute Lymphoblastic Leukemia with three arms.

The primary endpoints were met: statistically significant reduction of allergic reactions were observed. None of the 26 patients in the Graspa arm experienced an allergic reaction versus 12 of the 28 (42.9%) patients treated with reference L-asparaginase in the control group. in the Graspa group, asparaginase levels were maintained above 100 IU/l for an average of 20.5 days with up to 2 injections during the first month of treatment (induction phase) versus 9.2 days in the control group with up to 8 injections of reference L-asparaginase.

At the end of the induction phase, 15 patients (71.4%) in the Graspa arm show complete remission versus 11 patients (42.3%) in the control arm. Only 2 patients experiencing mild allergic reactions. Based on the results of the GRASPALL study and the earlier studies performed with Graspa, Erytech intends to submit its application dossier for European Marketing Authorization in the first half of 2015.