A phase II/III study of JZP-458 in patients with acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL) who are hypersensitive to E. coli-derived asparaginases was announced at the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program.
The pivotal, open-label, multicenter, dose confirmation, and pharmacokinetic (PK) study (NCT04145531) is enrolling those who have ≥1 course of asparaginase remaining in their treatment plan. Thereafter, 6 doses of JZP-458 will be substituted for each remaining course. Treatment duration will depend on the number of asparaginase courses remaining in the treatment plan.
“The inability to receive asparaginase second to hypersensitivity has been associated with poor patient outcomes,” Luke Maese, DO, assistant professor at the University of Utah School of Medicine in the Division of Pediatric Hematology/Oncology,…
