February 2016, Vol. 5, No. 1

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Nilotinib Yields Better Rates of Molecular Response Than Imatinib in the Frontline Setting

ASH 2015, ASH Highlights

Dose-optimized nilotinib increased the rates of major molecular response (MMR) in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) in the ENESTxtnd study. According to final results from this study, the cumulative MMR rate was 78.8% by 12 months and 81.0% by 24 months in patients managed with the dose-optimization strategy.

“The results from this study demonstrated the feasibility of nilotinib dose optimization with high response rates among patients with dose adjustments and a high rate of successful dose reescalation among patients with dose reductions,” said Timothy P. Hughes, MD, MBBS, FRACP, FRCP, South Australian Health and Medical Research Institute, University of Adelaide, Australia. “Overall, results from ENESTxtnd were consistent with those of prior studies and support frontline nilotinib for patients with newly diagnosed CML-CP.”

Use of frontline nilotinib in the ENESTnd study achieved earlier and higher rates of molecular response in CML-CP versus frontline imatinib. ENESTxtnd was conducted to investigate further the efficacy and safety of frontline nilotinib and to evaluate novel nilotinib dose-optimization strategies.

ENESTxtnd researchers enrolled a total of 421 newly diagnosed patients older than 18 years with no previous CML therapy and ECOG performance status 0 to 2.

Patients were treated with nilotinib (300 mg) with nilotinib dose optimization as recommended per study protocol. Dose escalation to 400 mg was permitted for all patients with suboptimal response or treatment failure.

Of 421 patients, 78% completed the 24-month protocol to remain on nilotinib, with only 22% discontinuing treatment. Of the patients who completed 24 months of treatment, 76% remained at 300 mg, 20% escalated to 400 mg, and 4% escalated to 450 mg.

Of the 144 patients who underwent dose reduction, 106 attempted dose reescalation, which was successful in 92 patients, Hughes reported.

“We are cautious in interpreting the data,” said Hughes, “but cumulative rates of major molecular response look extremely good compared to ENESTnd.”

By 12 months, 71% of patients had achieved MMR in ENESTxtnd compared with 55% of patients in ENESTnd, and by 24 months, 81% of ENESTxtnd patients had achieved MMR compared with 71% of ENESTnd patients.

The safety profile was similar to other reports of frontline nilotinib, Hughes noted.

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