Efficacy and Safety of Generic Dasatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase: A Multicenter Prospective Study in China.

Abstract

BACKGROUND:

Brand-name dasatinib was approved for newly diagnosed chronic myeloid leukemia-chronic phase (CML-CP) patients due to its deeper and faster molecular response than imatinib. Generics, as the alternative, low-cost forms, are much in demand. This study aimed to evaluate the efficacy and safety of generic dasatinib (Yinishu) as a first-line treatment in CML-CP.

MATERIALS AND METHODS:

This was a prospective, multicenter, single-arm study from May 2016 to October 2018 with a 2-year follow-up analysis. All patients were given 100 mg/d (initial dose) of the generic dasatinib once a day. The primary endpoint was the major molecular response (MMR) calculated based on the BCR-ABL1 gene mutation rate of ≤ .1% at 12 months.

RESULTS:

Among 55 patients in CP observed for at least 3 months, 80.4% achieved MMR at 12 months. The cumulative MR4.5 was 58.2% by 24 months. Responses occurred rapidly, with 69.1% of patients achieving complete cytogenetic response (CCyR) by 3 months and 70.9% achieving CCyR by 6 months. The estimated 2-year PFS and OS were both 96%, with a median follow-up time of 24 months. Grade 3 neutropenia occurred in 8.5% of patients, and thrombocytopenia occurred in 11.9% of patients. Nonhematologic toxicity was usually mild and manageable. Pleural effusion occurred in 20.3% of patients, and only 1 patient (1.7%) had a grade 3 pleural effusion. No grade 4 adverse events were observed.

CONCLUSION:

Generic dasatinib is an effective option for newly diagnosed CML-CP patients, producing an MMR early in a greater number of patients during their therapy.

• Authors: Wenjuan Yu, Xin Du, Weiguang Wang, Jin Lou, Peng Liu, Li Meng, Jie Jin
• Journal: Clinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 22 Issue 9 Pg. e867-e873 (09 2022) ISSN: 2152-2669 [Electronic] United States
• PMID: 35842355 (Publication Type: Journal Article, Multicenter Study)
• Copyright: Copyright © 2022. Published by Elsevier Inc.

Chemical References

• Antineoplastic Agents
• Drugs, Generic
• Protein Kinase Inhibitors
• Imatinib Mesylate
• Dasatinib

Topics

• Antineoplastic Agents (adverse effects)
• Dasatinib (adverse effects)
• Drugs, Generic (adverse effects)
• Humans
• Imatinib Mesylate (therapeutic use)
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)
• Leukemia, Myeloid, Chronic-Phase (drug therapy, genetics)
• Pleural Effusion
• Prospective Studies
• Protein Kinase Inhibitors (adverse effects)
• Treatment Outcome