Acute lymphoblastic leukemia (ALL) is a cancer of the blood and bone marrow that is the most common type of cancer in children in the US and Europe. More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20.
Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting toxicities. Hypersensitivity is one of the most common reasons for discontinuation of asparaginase therapy and is observed in up to 30% of patients. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.
Eryaspase has been evaluated in several trials in acute lymphoblastic leukemia (ALL). In particular, the encouraging clinical experience and feasibility of administering eryaspase to patients who had developed hypersensitivity to prior asparaginase provided the foundation for further evaluation in these patients.
An investigator sponsored Phase 2 trial conducted by the Nordic Organization for Pediatric Hematology & Oncology (NOPHO) evaluating the use of eryaspase in ALL patients who developed hypersensitivity reactions to pegylated asparaginase was initiated in 2016. The NOR-GRASPALL-2016 Trial enrolled 55 patients at 21 clinical sites in the Nordic and Baltic countries of Europe. Positive results in terms of asparaginase enzyme activity and safety were reported in the trial and presented at the American Society of Hematology 2020 Annual Meeting (https://doi.org/10.1182/blood-2020-139373).
Based on results of NOPHO-sponsored Phase 2 trial, the Company intends to seek approval for eryaspase for ALL patients who developed hypersensitivity to E.coli derived asparaginase in the United States and Europe.