Calaspargase pegol-mknl

(Asparlas®)

Calaspargase pegol-mknl

Drug updated on 9/4/2024

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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  • Asparlas (calaspargase pegol-mknl) is 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.
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Event-Free Survival (EFS): In children and adolescents with acute lymphoblastic leukemia (ALL), studies comparing different doses of PEG-asparaginase and calaspargase showed little to no difference in EFS across various dosing regimens (e.g., RR 1.01, 95% CI 0.97 to 1.06; RR 1.06, 95% CI 0.97 to 1.16; moderate-certainty evidence).
  • Overall Survival (OS): A study comparing six doses to two doses of PEG-asparaginase in children with standard low-risk ALL found little to no difference in OS (RR 0.99, 95% CI 0.98 to 1.00; moderate-certainty evidence).
  • Leukaemic Relapse: Treatment with 11 doses of calaspargase versus 16 doses of PEG-asparaginase in children and adolescents with standard- and high-risk ALL likely reduces leukaemic relapse (RR 0.32, 95% CI 0.12 to 0.83; moderate-certainty evidence).
  • Hypersensitivity: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in hypersensitivity compared to PEG-asparaginase (RR 1.17, 95% CI 0.64 to 2.13; low-certainty evidence).
  • Pancreatitis: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in pancreatitis compared to PEG-asparaginase (RR 0.85, 95% CI 0.47 to 1.52; low-certainty evidence).
  • Thromboembolism: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in thromboembolism compared to PEG-asparaginase (RR 0.83, 95% CI 0.48 to 1.42; low-certainty evidence).
  • Osteonecrosis: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in osteonecrosis compared to PEG-asparaginase (RR 0.63, 95% CI 0.15 to 2.56; low-certainty evidence).
  • Overall Asparaginase-Associated Toxicity: Calaspargase pegol-mknl (Asparlas) showed either no difference or a slight reduction in overall asparaginase-associated toxicity compared to PEG-asparaginase (RR 1.00, 95% CI 0.71 to 1.40; low-certainty evidence).
  • The evidence indicates that the studies primarily focused on children and adolescents with ALL, aged 1.0 to 21.0 years, with a specific subgroup analysis for children aged one to nine years in standard low-risk ALL. Outcomes were stratified by dosing regimens, showing age-dependent differences where children generally had better survival rates compared to older populations. These findings were observed across standard and high-risk ALL and lymphoblastic lymphoma populations.

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
Pegaspargase in practice: minimizing toxicity, maximizing benefit.2021Current Hematologic Malignancy Reports
Acute lymphoblastic leukemia, version 2.2021, NCCN clinical practice guidelines in oncology.2021Journal of the National Comprehensive Cancer Network
Pediatric acute lymphoblastic leukemia, version 2.2020.2020Journal of the National Comprehensive Cancer Network