Flumatinib Versus Imatinib for Chronic-Phase CML: Phase III FESTnd Trial
Posted: Tuesday, November 3, 2020
Flumatinib may prove to be a more effective first-line treatment than imatinib for patients with chronic-phase Philadelphia chromosome–positive chronic myeloid leukemia (CML), according to the FESTnd phase III clinical trial. Flumatinib was reported to be associated with faster and higher rates of major molecular response and lower rates of adverse events. Jianxiang Wang, MD, of the Chinese Academy of Medical Sciences, and colleagues published their results in Clinical Cancer Research.
“The FESTnd study suggested that flumatinib at a dose of 600 mg has an efficacy profile that is superior to imatinib and similar to second-generation tyrosine kinase inhibitors among patients with newly diagnosed chronic-phase chronic myeloid leukemia,” the authors wrote.
The randomized, open-label, multicenter trial included 394 patients with chronic-phase CML: 196 were randomly assigned to receive 600 mg of flumatinib once a day, and 198 were given 400 mg of imatinib once a day. All patients had Philadelphia chromosome–positive leukemia. Patients with impaired cardiac function were not eligible for the study.
At 6 months, the flumatinib arm had a higher rate of major molecular response (34%) than the imatinib arm (18%). The same was true at 12 months (53% vs. 40%, respectively). Early molecular response rate at 3 months also appeared to be better with flumatinib (82%) than with imatinib (53%).
At 12-month follow-up, patients who received flumatinib had lower rates of edema, pain in the extremities, rash, neutropenia, anemia, and hypophosphatemia than those who received imatinib. Use of flumatinib also was linked to higher rates of diarrhea and alanine transaminase elevation, but these adverse events were reported to be manageable. More long-term studies are needed to determine the durability of responses and the long-term cardiovascular safety of flumatinib.
Disclosure: The study authors’ disclosure information may be found at clincancerres.aacrjournals.org.