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JZP458 in ALL/LBL: Complete follow-up results from AALL1931 trial
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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 ALL Hub previously reported the primary results and post-hoc analysis results from this trial. Recently, 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.
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