Results from HARMONY: an open-label, multicentre, 2-arm, phase 1b, dose-finding study assessing the safety and efficacy of the oral combination of ruxolitinib and buparlisib in patients with myelofibrosis

to the best of our knowledge, HARMONY is the first study presenting safety and efficacy data on ruxolitinib and buparlisib combination in patients with MF. MTD for the combination was determined to be 15 mg bid for ruxo litinib and 60 mg qd for buparlisib in both JAKi-naïve and prior JAKi arms. 11 Individual MTDs were 25 mg bid for r uxolitinib a nd 100 mg qd for buparlisib. 12,13 In our study, MTD for the combination constituted lower doses for both the drugs when compared with the single agents. Additionally, no unexpected DLTs were observed with the combination. Thrombocytopenia, anxiety, and depression were the DLTs observed with the combination in our study, which are consistent with the known profile of these 2 drugs. 12,13 The combination was well tolerated with a manageable safety profile and provided clinically relevant efficacy. No new safety signals were observed.