February 20, 2018
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Treatment-free remission of chronic myeloid leukemia achievable after second-line nilotinib

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Patients with chronic myeloid leukemia who have attained sustained deep molecular response with second-line nilotinib therapy can achieve treatment-free remission for 48 weeks or longer, according to a study published in Annals of Internal Medicine.

“Treatment-free remission — that is, stopping tyrosine kinase inhibitor therapy without loss of response — is an emerging treatment goal in chronic myeloid leukemia,” François-Xavier Mahon, MD, PhD, from the University of Bordeaux, France, and colleagues wrote.

Mahon and colleagues performed a single-group, phase 2, open-label study to assess whether adults with chronic myeloid leukemia can maintain treatment-free remission after discontinuation of second-line nilotinib (Tasigna, Novartis) therapy.

The researchers enrolled 163 patients with Philadelphia chromosome–positive chronic myeloid leukemia in the chronic phase who received tyrosine kinase inhibitor therapy for 3 years or more (more than 4 weeks with imatinib, followed by 2 or more years of nilotinib) and achieved a deep molecular response of MR4.5 while receiving nilotinib. Participants entered a 1-year consolidation period where they received nilotinib.

Participants who sustained MR4.5 during consolidation entered treatment-free remission. They reinitiated nilotinib treatment if they had a major molecular response loss or confirmed MR4 loss.

Results showed that 126 patients entered the treatment-free remission period. Of those, treatment-free remission was maintained by 58% (95% CI, 49-67) at 48 weeks and 53% (95% CI, 44-62) at 96 weeks. Nilotinib was reinitiated by 56 patients; of those, most regained major molecular response or better (n = 55) and MR4.5 (n = 52). Progression of chronic myeloid leukemia to accelerated phase or blast crisis was not observed. In the initial 48 weeks after nilotinib discontinuation, musculoskeletal pain was more commonly reported.

“For those who do not achieve sustained [deep molecular response] with imatinib, switching to nilotinib may enable more patients to become eligible for [treatment-free remission],” Mahon and colleagues concluded. “Any decision regarding treatment switching also should take into account the benefits and risks of the [tyrosine kinase inhibitors], including toxicity profiles.”

“These findings demonstrate a high [treatment-free remission] rate in a selected population of patients who achieved sustained [deep molecular response] only after switching from imatinib to nilotinib therapy,” they added. – by Alaina Tedesco

Disclosure: Mahon reports receiving honoraria from Bristol-Myers Squibb, Novartis Pharma and Pfizer; having advisory board membership in Bristol-Myers Squibb, Novartis Pharma and Ariad/Incyte; and receiving research support from Novartis Pharma. Please see study for all other authors’ relevant financial disclosures.