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EHA25 Virtual: Nilotinib in Patients With CML Who Relapse After Discontinuing Imatinib

By: Kelly M. Hennessey, PhD
Posted: Tuesday, June 23, 2020

Many patients with chronic myeloid leukemia (CML) achieve a high rate of deep molecular response with tyrosine kinase inhibitor treatment and are able to discontinue therapy. However, more than 50% of those who stop treatment experience molecular recurrence. In the French Nilo POST-STIM trial, Stephanie Dulucq, PhD, of Bordeaux University Hospital, Pessac, France, and colleagues found that nilotinib after a failed first stop of imatinib yielded sustained deep molecular response and may make a second attempt at treatment-free remission possible. These results were presented during the virtual edition of the 25th European Hematology Association Annual Congress (EHA25 Virtual; Abstract EP751).

Included in the study were 31 patients from either the EUROSKI or STIM2 clinical trial (n = 16 and n = 9, respectively) or who received treatment according to the STIM2 protocol (n = 6). Of those 31 patients, cumulative adverse effects caused 22% of them (n = 7) to discontinue treatment at 6 months, whereas 1 patient withdrew voluntarily. Patients remaining in the study (n = 23) continued treatment with nilotinib for 2 years

All 23 patients reached molecular response 4.5, and 22 patients (96%) maintained molecular response during at least 1 year of nilotinib and then discontinued treatment. Molecular recurrence occurred in 35% of patients with at least 6 months of follow -up after treatment discontinuation (n = 20), and the median time to molecular recurrence was 4.1 months.

“Nilotinib treatment induces a high rate of sustained deep molecular response and can lead to successful second treatment-free remission attempt in patients having previously failed a first stop of imatinib. However, molecular recurrence-free survival is not better than those already reported,” explained the researchers.

Disclosure: For disclosures of the study authors, visit

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