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Although many chronic myeloid leukemia (CML) patients initially do well with tyrosine kinase inhibitors (TKIs), some patients develop resistance or intolerance to multiple TKIs and need further therapy. Omacetaxine mepesuccinate (omacetaxine), a protein synthesis inhibitor, represents a new class of treatment that can produce major cytogenetic response (MCyR) in patients with CML who have developed resistance or intolerance to TKIs. The US Food and Drug Administration approved subcutaneous omacetaxine for treatment of CML in chronic-phase (CP) and accelerated-phase patients, with resistance or intolerance to two or more TKIs based on efficacy analysis of a subset of patients from two phase 2, open-label, international, multicenter studies.1, 2 Among the 76 evaluable patients with CML-CP in the efficacy analysis, MCyR was reported in 14 patients (18.4%), including confirmed complete cytogenetic response (CCyR) in six patients (7.9%), with a median MCyR duration of 12.5 months.2, 3 Median progression-free survival (PFS) and overall survival (OS) in CML-CP patients were 9.6 months (95% confidence interval (CI) 6.8–11.3 months) and 40.3 months (95% CI 23.8 months–not reached), respectively.

blood cancer journal

Prediction of response and survival in patients with chronic-phase chronic myeloid leukemia treated with omacetaxine mepesuccinate: logistic regression and landmark analyses