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2025-01-01T13:19:52.000Z

JZP458 in ALL/LBL: Complete follow-up results from AALL1931 trial

Jan 1, 2025
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Learning objective: After reading this article, learners will be able to cite a new clinical development in lymphoma.

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The phase II/III ALL1931 trial (NCT04145531) assessed the efficacy and safety of JZP458, a recombinant Erwinia asparaginase, in children and adult patients with ALL or LBL who had developed sensitivity to Escherichia coli-derived asparaginases. The complete follow-up results from the trial were published in Blood Advances by Maese. The study evaluated the efficacy and safety of different doses of JZP458 administered MWF in 2 cohorts (IM and IV). The primary efficacy endpoint was safety and the proportion of patients achieving NSAA level of ≥0.1 IU/mL in the last 72 hours during Course 1 of IM JZP458.1 


Key learnings
The proportion of patients reaching the NSAA level of ≥0.1 IU/mL in the last 72 hours was 64% in the IM 25 mg/m², 91% in the IM 37.5 mg/m², 90% in the IM 25/25/50 mg/m² cohort, and 40% in the IV 25/25/50 mg/m² cohort. 
The frequency of serious TRAEs was 29% and 48% in the IM and IV cohorts, respectively.  
Treatment discontinuation was reported in the 23% and 56% of patients in the IM and IV cohorts due to TRAEs (mainly allergic reactions and pancreatitis). 
The complete follow-up results from the ALL1931 trial support the use of JZP458 in patients with ALL/LBL who are hypersensitive to Escherichia coli-derived asparaginases. 

Abbreviations: ALL, acute lymphoblastic leukemia; IM intramuscular; IV, intravenous; LBL, lymphoblastic lymphoma; MWF, Monday/Wednesday/Friday; NSAA, nadir serum asparaginase activity; TRAE, treatment-related adverse event. 

  1. Maese LD, Loh ML, Agarwal MR, et al. Recombinant Erwinia Asparaginase (JZP458) in ALL/LBL: Complete follow-up of the children's oncology group AALL1931 study. Blood Adv. 2024. Online ahead of print. DOI: 10.1182/bloodadvances.2024013346 

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