title: 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.affiliation: State Key Laboratory of Experimental Hematology, Department of Clinical Hematology, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China;
authors.forename: Jianxiang
authors.initials: J
authors.lastname: Wang
authors.affiliation: Shanghai Institute of Hematology, Shanghai Ruijin Hospital, Shanghai, China;
authors.forename: Zhi-Xiang
authors.initials: ZX
authors.lastname: Shen
authors.affiliation: Department of Clinical and Biological Sciences, San Luigi Hospital, University of Turin, Orbassano, Italy;
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Saglio
authors.affiliation: Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang Province, China;
authors.forename: Jie
authors.initials: J
authors.lastname: Jin
authors.affiliation: Department of Hematology, The First Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, Zhejiang Province, China;
authors.forename: He
authors.initials: H
authors.lastname: Huang
authors.affiliation: Institute of Hematology, Wuhan Union Hospital, Tongji Medical College, Wuhan Hubei, China;
authors.forename: Yu
authors.initials: Y
authors.lastname: Hu
authors.affiliation: Department of Hematology, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou Guangdong, China;
authors.forename: Xin
authors.initials: X
authors.lastname: Du
authors.affiliation: Department of Hematology, Jiangsu Province People's Hospital, Nan Jing, China;
authors.forename: Jianyong
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Hematology, Nanfang Hospital, Guangzhou Southern Medical University, Guangzhou Guangdong, China;
authors.forename: Fanyi
authors.initials: F
authors.lastname: Meng
authors.affiliation: Department of Hematology, West China Hospital of Sichuan University, Chengdu Sichuan, China;
authors.forename: Huanling
authors.initials: H
authors.lastname: Zhu
authors.affiliation: Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, China;
authors.forename: Jianda
authors.initials: J
authors.lastname: Hu
authors.affiliation: Department of Hematology, Changhai Hospital, The Second Military Medical University, Shanghai, China;
authors.forename: Jianmin
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Hematology, Qilu Hospital, Shandong University, Jinan, China;
authors.forename: Ming
authors.initials: M
authors.lastname: Hou
authors.affiliation: Novartis Pharma AG, Basel, Switzerland;
authors.forename: Sabine
authors.initials: S
authors.lastname: Hertle
authors.affiliation: Novartis Pharma AG, Basel, Switzerland;
authors.forename: Hans D
authors.initials: HD
authors.lastname: Menssen
authors.affiliation: Novartis Pharma AG, Basel, Switzerland;
authors.forename: Christine-Elke
authors.initials: CE
authors.lastname: Ortmann
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ;
authors.forename: Catherine
authors.initials: C
authors.lastname: Tribouley
authors.affiliation: Beijing Novartis Pharma Company, Limited, Beijing, China;
authors.forename: Ye
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: Department of Hematology-Oncology, and the Department of Experimental, Diagnostic, and Specialty Medicine, University of Bologna, Bologna, Italy; and.
authors.forename: Michele
authors.initials: M
authors.lastname: Baccarani
authors.affiliation: Peking University People's Hospital and Institute of Hematology, Beijing, China.
authors.forename: Xiaojun
authors.initials: X
authors.lastname: Huang
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001549:Benzamides / Q000627:therapeutic use*; D002681:China; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010879:Piperazines / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate; C498826:nilotinib