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JZP458 in ALL/LBL: Post hoc analysis from AALL1931 trial
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Results from the post hoc analysis of the ALL1931 trial (NCT04145531) of JZP458 in children and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic leukemia who had developed sensitivity to Escherichia coli-derived asparaginases were presented during the European Hematology Association (EHA) 2024 Hybrid Congress by Maese.1 The analysis evaluated different doses of JZP458 in two cohorts (intramuscular [IM] and intravenous [IV] cohorts) of 112 patients and reported on adverse events (AEs) of interest and nausea/vomiting.1 |
| Key learnings |
| The frequency of any-grade treatment-related allergic reactions was 11% and 26% in the IM cohort and IV cohorts, respectively. |
| Increase in alanine aminotransferase (ALT)/aspartate aminotransferase (AST) was 16% and 18% in the IM cohort and IV cohorts, respectively. |
| Treatment-related Grade ≥2 nausea/vomiting events was 21% and 61% in the IM cohort and IV cohorts, respectively. |
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Grade ≥2 nausea/vomiting events in the IM and IV cohorts were:
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| Any-grade treatment-related allergic reactions, pancreatitis, thrombosis, increased ALT/AST, and increased bilirubin was similar across age groups and between the Hispanic patients (n = 74) and non-Hispanic patients (n = 140). |
| The safety data from this post hoc analysis of the ALL1931 trial support the use of JZP458 in patients with ALL/LBL who are hypersensitive to Escherichia coli-derived asparaginases. |
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