Summary

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• This summary is based on the review of one randomized controlled trial(s). ^[1]
• In the study evaluating IM JZP458, the primary efficacy outcome was the maintenance of adequate nadir serum asparaginase activity (NSAA) levels (NSAA ≥ 0.1 IU/mL). Across the three dosing regimens, the highest efficacy was observed in Cohort 1c (25/25/50 mg/m² MWF), with 90% of patients maintaining NSAA ≥ 0.1 IU/mL at 72 hours and 96% at 48 hours.
• In Cohort 1b (37.5 mg/m² MWF), mean NSAA levels were 0.33 IU/mL at 72 hours and 0.88 IU/mL at 48 hours. In Cohort 1a (25 mg/m² MWF), mean NSAA levels were lower, at 0.16 IU/mL at 72 hours and 0.45 IU/mL at 48 hours.
• The study population included patients with acute lymphoblastic leukemia/lymphoblastic lymphoma who had hypersensitivity or silent inactivation to E. coli-derived asparaginases, but no significant differences in efficacy between specific subgroups were highlighted.
• Treatment-related adverse events (TRAEs) of grade 3 or 4 severity occurred in 51% of patients (86 out of 167). Key adverse events leading to treatment discontinuation included pancreatitis (6%), allergic reactions (5%), increased alanine aminotransferase (ALT) (1%), and hyperammonemia (1%).
• The safety profile of IM JZP458 was reported as consistent with other asparaginase products, with no significant safety concerns or adverse effects specifically highlighted for different population subgroups within the study.