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Eryaspase for ALL: Results from the NOR-GRASPALL-2016 study

Apr 8, 2022
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On April 6, 2022, results of the single arm, phase II NOR-GRASPALL 2016 study (NCT03267030) investigating eryaspase for the treatment of patients with acute lymphoblastic leukemia (ALL), were announced. The multinational study sought to evaluate the safety and asparaginase enzyme activity of eryaspase in patients who had suffered hypersensitivity reactions to prior pegylated asparaginase therapy; both objectives were met.1

When combined with chemotherapy, eryaspase demonstrated a favorable tolerability profile; two of the 55 enrolled patients withdrew treatment due to severe hypersensitivity reactions. Asparaginase enzyme activity exceeded the threshold (trough level, >100 U/L) 14 days after initial eryaspase infusion in 92.5% of patients.

Click here to access the results from the NOR-GRASPALL-2016 study as published by Lynggaard, et al., in the British Journal of Haematology.2

Eryaspase

Eryaspase is a donor-derived erythrocyte-encapsulated L-asparaginase product that targets asparagine and glutamine metabolism in cancer cells. Design rationale include prolonged half-life and reduced toxicity when compared with conventional asparaginase delivery methods.1

The U.S. Food and Drug Administration (FDA) granted Fast Track designation to eryaspase in July 2021 for the treatment of patients with ALL and pancreatic cancer who have experienced allergic reactions to E. coli-derived pegylated asparaginase.3 Eryaspase also received orphan drug status from both the FDA and European Medicines Agency (EMA) for the same indications.

  1. ERYTECH announces publication of positive results from eryaspase phase 2 trial in hypersensitive ALL in the British Journal of Haematology. https://www.globenewswire.com/news-release/2022/04/06/2417989/0/en/ERYTECH-Announces-Publication-of-Positive-Results-from-Eryaspase-Phase-2-Trial-in-Hypersensitive-ALL-in-the-British-Journal-of-Haematology.html. Published Apr 6, 2022. Accessed Apr 7, 2022.
  2. Lynggaard LS, Vaitkeviciene G, Langenskiöld C, et al. Asparaginase encapsulated in erythrocytes as second-line treatment in hypersensitive patients with acute lymphoblastic leukaemia. Br J Haematol. 2022. Online ahead of print. DOI: 1111/bjh.18152
  3. ERYTECH granted U.S. FDA Fast Track designation for eryaspase in hypersensitive ALL. https://investors.erytech.com/news-releases/news-release-details/erytech-granted-us-fda-fast-track-designation-eryaspase. Published Jul 29, 2021. Accessed Apr 7, 2022.

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