Nilotinib Benefits Relapsed Patients With CML After Treatment Discontinuation

Jorge E. Cortes, MD, deputy chair of the Department of Leukemia in the Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center, discusses the results from the ENESTFreedom study (NCT01784068), which evaluated the use of nilotinib (Tasigna) as a treatment for patients with BCR-ABL1—positive chronic myeloid leukemia (CML) in the chronic phase.

The ENESTFreedom trial looks at nilotinib in the frontline for patients with CML. As this agent has already been approved for a number of years, Cortes says it is known that nilotinib can give patients a better probability of achieving sustained deep molecular responses (MRs). The rate of MR4.5 at 5 years is close to 60% and the incidence of sustained MR4.5 for at least 2 years is 40% to 45%. Cortes adds that this probably continues to increase over time, but these are data after 5 years of follow-up.

This trial was able to answer the question of what happens to patients after they stop treatment on nilotinib. Data show that about half of the patients are able to discontinue nilotinib and remain off treatment, just like with the tyrosine kinase inhibitors imatinib (Gleevec) and dasantinib (Sprycel). Although 85% of all relapses after nilotinib discontinuation occur within the first 6 months off treatment, the rate of incidences of relapse decreases significantly after 6 months.