Blood: The new drug for leukemia! Recombinant Irving bacterium asparagine enzyme JZP458 Phase 2/3 test results are effective and safe!

Asparaginase is a bacterial protein that has been used to treat acute lymphoblastic leukemia (ALL) and lymphocytic lymphoma (LBL) and has high potential for sensitization and immunogenicity

AALL1931 is a Phase 2/3 study conducted in collaboration with the Pediatric Oncology Gene Association to evaluate the efficacy and safety

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A total of 167 patients were enrolled: Cohort 1a (n=33), Cohort 1b (n=83), and Cohort 1c (n=51).

The mean SAA levels (IU/mL) for the 72nd hour of Cohort 1a, Cohort 1b, and Cohort 1c were 0.

Grade 3/4 treatment-related adverse events (TRAEs) occurred in 86/167 (51%) patients with TRAEs that led to treatment interruption included pancreatitis (6%), anaphylaxis (5%), elevated alanine aminotransferase (1%), and hyperammonia (1%)

Overall, the findings show that JZP458 (intramuscular injection) of the Monday/Wednesday/Friday 25/25/50 mg/m2 dose regimen is effective in patients with acute lymphoblastic leukemia/lymphoblastic lymphoma, and its safety is consistent

Original Source:

Maese Luke D,Loh Mignon L,Choi Mi Rim et al.