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Nilotinib Benefits Relapsed Patients With CML After Treatment Discontinuation

Jorges E. Cortes, MD
Published Online:1:13 PM, Tue June 18, 2019

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.

Cortes concludes that the majority of patients that lose their response after discontinuation are able to go back on treatment with nilotinib. The reason these patients relapsed was because the treatment was stopped; overall, the patients were responsive to re-treatment with nilotinib and tolerated treatment well, so putting them back on treatment is possible.
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