Final Data Analysis for Omacetaxine in Chronic, Accelerated Phase Chronic Myeloid Leukemia

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Patients with chronic phase or accelerated phase chronic myeloid leukemia that is resistant and/or intolerant to two or more tyrosine kinase inhibitors can currently receive omacetaxine, a protein synthesis inhibitor.

The final analysis of omacetaxine, which included 24 months of follow-up, revealed additional safety and efficacy information to demonstrate the benefit of long-term omacetaxine administration in patients with chronic phase or accelerated phase chronic myeloid leukemia who received more than 3 cycles of treatment (1.25 mg/m2 twice daily for 14 days every 28 days followed by 7 days every 28 days).

The data showed that 18% of patients with chronic phase chronic myeloid leukemia achieved a major cytogenetic response that lasted a median of 12.5 months. The responses lasted for 12 months or more in three of 14 responders, and the rate of overall survival was a media of 40.3 months (95% CI, 23.8 months to NR). In patients with accelerated phase chronic myeloid leukemia, 14% of patients had a major hematologic response for a median of 4.7 months (95% CI, 3.6 months to NR).

In patients with accelerated phase chronic myeloid leukemia a major cytogenetic response was not seen and there was a median overall survival of 14.3 months (95% CI, 6.7, 18.7 months). There were 50 patients with chronic phase chronic myeloid leukemia who received more than 3 cycles of treatment and 14 patients with accelerated phase chronic myeloid leukemia who received more than 3 cycles of treatment. The median overall survival in these groups were 49.3 months (95% CI, 23.8 months to not reached) and 24.6 months (95% CI, 12, 37.2 months), respectively.

The most prominent side effects were grade 3 or higher hematologic toxicities (79% and 73% for chronic phase chronic myeloid leukemia and accelerated phase chronic myeloid leukemia, respectively). Ten percent of patients with chronic phase disease discontinued treatment because of toxicity and 5% of accelerated phase patients discontinued treatment because of toxicity.

Isolated testicular relapse in children with ALL is associated with improved outcomes.
Patients with chronic myeloid leukemia that is resistant to two or more tyrosine kinase inhibitors can currently receive omacetaxine.
Omacetaxine, a protein synthesis inhibitor, is indicated in the United States for the treatment of patients with chronic-phase (CP) or accelerated-phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors.
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