Safety and Efficacy of Nilotinib vs. Imatinib in the Treatment of Newly Diagnosed Chinese Ph+ CML-CP Patients

Summary

The study will compare the efficacy and safety of Nilotinib versus Imatinib in newly diagnosed Chinese patients with CML-CP.

Timeline

Start

2011-04

Primary completion

2014-10

Completion

2014-10

Outcome

Met primary endpoint

paper ENESTchina met its primary end point with a statistically significant higher rate of major molecular response PMID 25766724 ↗

registry NUMBER Imatinib: 27.8 (20.4 to 36.3) Percentage of Participants NCT01275196 ↗

registry NUMBER Nilotinib: 52.2 (43.4 to 60.9) Percentage of Participants NCT01275196 ↗

registry analysis (non-inferiority or equivalence test); Imatinib vs Nilotinib; p = 0.0001; Cochran-Mantel-Haenszel NCT01275196 ↗

Publications

• Wang J, Shen ZX, Saglio G, Jin J, Huang H, Hu Y, Du X, Li J, Meng F, Zhu H, Hu J, Wang J, Hou M, Hertle S, Menssen HD, Ortmann CE, Tribouley C, Yuan Y, Baccarani M, Huang X. Phase 3 study of nilotinib vs imatinib in Chinese patients with newly diagnosed chronic myeloid leukemia in chronic phase: ENESTchina. Blood. 2015 Apr 30;125(18):2771-8. doi: 10.1182/blood-2014-09-601674. Epub 2015 Mar 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Imatinib	Small molecule	400 mg	—
Subject	Nilotinib	Small molecule	300 mg	—

Indications