On June 9, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported an update on the ongoing Phase 2 trial, sponsored by the Nordic Society of Paediatric Haematology and Oncology (NOPHO) of eryaspase in second-line acute lymphoblastic leukemia (ALL) patients (Press release, ERYtech Pharma, JUN 9, 2020, View Source [SID1234560929]).
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The NOR-GRASPALL-2016 trial is evaluating the safety and activity of eryaspase in primarily pediatric acute lymphoblastic leukemia (ALL) patients who developed hypersensitivity reactions to pegylated asparaginase. The trial which is being conducted at 22 clinical sites in the Nordic and Baltic countries of Europe has reached its target enrollment of 50 patients.
Preliminary findings of the study suggest that eryaspase achieved the target level and duration of asparaginase activity in these patients. Additionally, the addition of eryaspase to the combination chemotherapy was associated with an acceptable tolerability profile, enabling the majority of these patients to receive their fully intended courses of asparginase. Recent data have confirmed that discontinuation of asparaginase therapy in ALL patients has been associated with inferior disease free survival1.
"Hypersensitivity to asparaginase remains an important concern in the treatment of ALL patients," said Dr Birgitte Klug Albertsen, Associate Professor at Aarhus University Hospital, Denmark, and Principal Investigator of the trial. "Based on the results we have observed thus far, eryaspase appears to have promise as a novel approach to continue asparaginase-based therapy for patients who develop hypersensitivity to pegylated asparaginase. We look forward to sharing the full results of the trial at a future medical congress."
"Initial feedback obtained from FDA has confirmed that ALL patients experiencing hypersensitivity to pegylated asparaginase represents an unmet medical need given the limited available treatment choices for these patients," said Dr Iman El Hariry, Chief Medical Officer of ERYTECH Pharma. "The encouraging evidence of activity in the NOPHO trial could provide support that eryaspase may serve as an additional potential therapeutic option in this patient population. We plan to further discuss these data with FDA as they mature to determine the appropriate next steps and assess a potential path forward for eryaspase in this setting."
About Acute Lymphoblastic Leukemia
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.2,3 More than 13,000 cases are diagnosed in the US and Europe each year with the majority of patients diagnosed before age 20.4-6 Asparaginase has been an integral component of ALL treatment for several years but is associated with treatment-limiting hypersensitivity in up to 30% of patients7. Discontinuation of asparaginase therapy in ALL patients has been associated with inferior event free survival highlighting the need for additional asparaginase based treatment options.