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Lyophilized pegaspargase for Japanese patients with B-ALL: Results from a phase II trial
Pegaspargase, a pegylated formulation of E. coli-derived asparaginase, combined with multi-agent chemotherapy is a well-established treatment for patients with ALL.1 Pegaspargase was developed initially as a liquid formulation; however, a lyophilized formulation was developed subsequently to improve stability and ensure continuous drug availability.1 A multicenter, open-label, single-arm, phase II trial (NCT04067518) assessed the pharmacokinetics, efficacy, and safety of lyophilized pegaspargase combined with multi-agent chemotherapy in newly diagnosed, previously untreated children and AYA patients with B-ALL in Japan (N = 26).1 Results from this trial were published in the International Journal of Hematology by Koh et al.1
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Key learnings |
Sustained plasma asparaginase activity ≥0.1 IU/mL was observed 5 minutes after the first dose and was maintained for 14 days in 100% of evaluable patients. |
The ORR was 100%, and the 1-year EFS and OS rates were both 100%. |
All patients experienced ≥1 TEAEs related to pegaspargase, most commonly decreases in blood fibrinogen, antithrombin III, white blood cell count, and platelet count, which were consistent with the known safety profile of pegaspargase. No deaths were reported. |
Results from this trial suggest that lyophilized pegaspargase combined with multi-agent chemotherapy is an effective first-line therapy for children and AYA patients with B-ALL in Japan. |
Abbreviations: ALL, acute lymphoblastic leukemia; AYA, adolescent and young adult; B-ALL, B-cell ALL; EFS, event-free survival; ORR, overall response rate; OS, overall survival; TEAE, treatment-emergent adverse event.
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