Nilotinib showed promise in imatinib-resistant/intolerant CML
Click Here to Manage Email Alerts
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.”