Calaspargase pegol-mknl

(Asparlas®)

Calaspargase pegol-mknl

Drug updated on 10/29/2024

Dosage FormInjection (intravenous; 3,750 units/5 mL)
Drug ClassAsparagine specific enzymes
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients aged 1 month to 21 years.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • No significant difference in Event-Free Survival (EFS) or Overall Survival (OS) was observed between intermittent PEG-asparaginase (eight doses) and continuous PEG-asparaginase (15 doses) in non-high risk acute lymphoblastic leukemia (ALL) patients, as well as between low-risk standard treatment with additional PEG-asparaginase (six doses) and standard treatment (two doses), with risk ratios (RR) close to 1.
  • Calaspargase (11 doses) showed a significant reduction in leukemic relapse compared to PEG-asparaginase (16 doses) with an RR of 0.32 (95% CI: 0.12 to 0.83), but no significant difference in EFS (RR 1.06).
  • PEG-asparaginase administered intermittently (eight doses) compared to continuous treatment (15 doses) was associated with reduced pancreatitis (RR 0.31) and asparaginase-associated toxicity (RR 0.53), but possible reduction in hypersensitivity (RR 0.64) and thromboembolism (RR 0.55) showed less conclusive results.
  • In comparison, adding PEG-asparaginase to low-risk standard treatment increased hypersensitivity (RR 12.05) and pancreatitis (RR 4.84) without a significant difference in thromboembolism or osteonecrosis.
  • PEG-asparaginase was primarily studied in children and adolescents aged 1.0 to 17.9 years with non-high risk acute lymphoblastic leukemia (ALL) and in participants aged 1 to 9 years with low-risk ALL. Additionally, Calaspargase was studied in adolescents and young adults (AYA) up to 21 years old with standard- and high-risk ALL and lymphoblastic lymphoma, showing reduced leukemic relapse compared to PEG-asparaginase in this group.

Product Monograph / Prescribing Information

Document TitleYearSource
Asparlas (calaspargase pegol-mknl) Prescribing Information.2023Servier Pharmaceuticals LLC, Boston, MA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
Pediatric acute lymphoblastic leukemia, version 2.2020.2020Journal of the National Comprehensive Cancer Network