Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina.

Abstract

Treatment with a tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 is currently the standard of care for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP). In this study, we present results of the ENESTchina (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-China) that was conducted to investigate nilotinib 300 mg twice daily vs imatinib 400 mg once daily in a Chinese population. ENESTchina met its primary end point with a statistically significant higher rate of major molecular response (MMR; BCR-ABL1 ≤0.1% on the International Scale) at 12 months in the nilotinib arm vs the imatinib arm (52.2% vs 27.8%; P < .0001), and MMR rates remained higher with nilotinib vs imatinib throughout the follow-up period. Rates of complete cytogenetic response (0% Philadelphia chromosome-positive [Ph+] metaphases by standard cytogenetics) were comparable and ≥80% by 24 months in both arms. The estimated rate of freedom from progression to accelerated phase/blast crisis at 24 months was 95.4% in each arm. The safety profiles of both drugs were similar to those from previous studies. In conclusion, rates of MMR at 12 months were superior with nilotinib vs imatinib in Chinese patients with newly diagnosed Ph+ CML-CP. This trial was registered at www.clinicaltrials.gov as #NCT01275196.

• Authors: Jianxiang Wang, Zhi-Xiang Shen, Giuseppe Saglio, Jie Jin, He Huang, Yu Hu, Xin Du, Jianyong Li, Fanyi Meng, Huanling Zhu, Jianda Hu, Jianmin Wang, Ming Hou, Sabine Hertle, Hans D Menssen, Christine-Elke Ortmann, Catherine Tribouley, Ye Yuan, Michele Baccarani, Xiaojun Huang
• Journal: Blood (Blood) Vol. 125 Issue 18 Pg. 2771-8 (Apr 30 2015) ISSN: 1528-0020 [Electronic] United States
• PMID: 25766724 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 by The American Society of Hematology.

Chemical References

• Antineoplastic Agents
• Benzamides
• Piperazines
• Pyrimidines
• Imatinib Mesylate
• nilotinib

Topics

• Adolescent
• Adult
• Aged
• Antineoplastic Agents (therapeutic use)
• Benzamides (therapeutic use)
• China
• Female
• Humans
• Imatinib Mesylate
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)
• Leukemia, Myeloid, Chronic-Phase (drug therapy)
• Male
• Middle Aged
• Neoadjuvant Therapy
• Piperazines (therapeutic use)
• Pyrimidines (therapeutic use)
• Treatment Outcome
• Young Adult