Abstract
BACKGROUND: Biosimilar pegylated L-asparaginase offers a promising alternative to the innovator molecule for treating acute lymphoblastic leukemia (ALL) in Indian children. It addresses challenges associated with drug availability and cost while providing similar therapeutic advantages. This biosimilar ensures wider access to essential treatment in resource-limited settings such as India. MATERIALS AND METHODS: A retrospective study was conducted at the Pediatric Oncology unit of the Department of Medical Oncology, Sher-I-Kashmir Institute of Medical Sciences (SKIMS) Srinagar. The study evaluated the efficacy and safety of biosimilar polyethylene glycol-asparaginase (PEG-ASP) (Asviia) in newly diagnosed pediatric ALL patients treated between January 2021 and December 2023. Each patient received two induction doses of PEG-ASP. RESULTS: The study included 45 patients (29 boys, 16 girls) with a median age of 7.5 years (range: 1-16 years), with most patients diagnosed with Pre-B ALL. The median PEG-ASP dose administered intravenously was 1175 IU (range: 1125-3750 IU). Significant improvements in hemoglobin and platelet counts were observed following the first dose of PEG-ASP. The biosimilar PEG-ASP was well tolerated, with no life-threatening events reported. At the end of the induction phase, 40 patients (88.89%) achieved complete remission with minimal residual disease (MRD) negativity, while five patients had MRD positivity. CONCLUSION: The study provides valuable insights into the efficacy and safety of biosimilar PEG-ASP for pediatric ALL in resource-limited settings, with strong data on remission rates and minimal adverse events.