August 31, 2012
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Nilotinib showed promise in imatinib-resistant/intolerant CML

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Nilotinib demonstrated an OS benefit among patients with chronic myeloid leukemia in the chronic phase that was resistant or intolerant to imatinib, according to results of a phase 2 study.

The researchers analyzed 48-month follow-up data for 321 patients with CML in the chronic phase who had been treated with nilotinib (Tasigna, Novartis) after imatinib (Gleevec, Novartis) resistance or intolerance.

The 98 patients (31%) who underwent treatment for the full 48 months were included in the final analysis.

During the study period, researchers observed a major cytogenetic response in 59% of patients, and a complete cytogenetic response in 45% of patients.

At the 48-month mark, estimated OS was 78% and estimated PFS was 57%. Patients with deeper levels of molecular response at 3 months and 6 months had a high correlation with OS and PFS at 48 months.

Disease progression (30%) and adverse events (21%) were the most common reasons cited for discontinuation.

“Nilotinib is safe and effective for long-term use in responding patients with [chronic myeloid leukemia in the chronic phase] who are intolerant of or resistant to imatinib,” the researchers concluded. “Further significant improvements in therapy are required for patients who are resistant or intolerant to imatinib.”