ERYTECH announces granting of new patent in the United States

23-Oct-2014 - USA

ERYTECH reports positive Phase III results from its pivotal study with GRASPA(R) 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(R). 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 (ALL) with three arms. The first two arms compare GRASPA(R) to native E. Coli L-asparaginase, both in combination with standard chemotherapy (COOPRALL), in a 1-to-1 randomization in patients without prior allergies to L-asparaginase. The third arm is an open label assessment of GRASPA(R) for patients who have experienced allergic reactions related to asparaginase in their first line treatment.

The primary endpoint of the study consisted of two objectives, in accordance with CHMP advice: a) superior safety, expressed as a significant reduction of the incidence of allergic reactions with GRASPA(R) compared to the control group, and b) non-inferior duration of asparaginase activity above the threshold of 100 IU/l during the induction phase in the non-allergic patients. Both endpoints needed to be met for the study to be considered positive. The main secondary efficacy endpoints included the assessment of clinical parameters such as complete remission (CR), minimal residual disease (MRD), event-free survival (EFS) and overall survival (OS).

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