Optimizing olverembatinib dose in chronic phase chronic myeloid leukemia.

Abstract

Optimizing olverembatinib dose in people with chronic phase chronic myeloid leukemia (CML) is important to increase safety without compromising efficacy. We designed a multi-center retrospective study comparing safety and efficacy of olverembatinib between the recommended dose of 40 mg every other day (QOD; N = 216) and a reduced dose of 30 mg QOD (N = 66) in subjects failing other tyrosine kinase-inhibitors (TKIs). The cohorts were similar in baseline co-variates and adjusted for by propensity score matching (PSM). There were no significant differences in cytogenetic and molecular responses, as well as outcomes between the 2 dose cohorts. However, the proportion of subjects receiving the original olverembatinib dose at the last follow-up was significantly higher in the 30 mg cohort (64% [95%Confidence Interval [CI], 53, 75%] versus 44% [37,51%]; p = 0.004). Also, the proportion of subjects receiving a reduced dose or permanently discontinuing because of adverse event was significantly lower in the 30 mg cohort (21% [9, 33%] versus 41% [34, 48%]; p = 0.003). In summary, olverembatinib, 30 mg QOD starting dose is as effective as a 40 mg starting dose but better tolerated in persons with chronic phase CML failing other TKIs.