achieved SVR35 (median change -50%; range: -84.4%, 23.7%) and 57% (34/60) pts achieved
TSS50 (median change -59%; range: -100%, 225%). Additionally, 33% (16/48) of pts had at
least one grade improvement in bone marrow fibrosis.
78 pts were evaluable for safety. Median exposure was 40 wks. The most common
hematological treatment-emergent adverse events (TEAEs) of any grade were anemia (33%,
≥Gr3: 30%) and thrombocytopenia (32%, ≥Gr3: 8%). These cytopenias were generally
manageable with dose modifications. The most common non-hematological TEAEs (≥15%)
were diarrhea (30%, no ≥Gr3), dysgeusia (19%, no ≥Gr3), asthenic conditions (19%, no ≥Gr3),
musculoskeletal pain (19%, no ≥Gr3), respiratory tract infections (18%, ≥Gr3: 1%), nausea
(17%, no ≥Gr3), abdominal pain (17%, no ≥Gr3), and dizziness (17%, no ≥Gr3).
CPI-0610 + rux combination is generally well-tolerated in JAKi-treatment-naïve MF pts. The
encouraging clinical data demonstrate the potential for the combination treatment to provide
enhanced efficacy as evidenced by higher SVR35 and TSS50 rates at wk 24 compared with
historical data from pivotal phase 3 studies. Overall, the data suggest that the addition of CPI-
0610 to rux is potentially synergistic in JAKi-naïve MF pts. A phase 3, randomized, double blind,
active-control study to further evaluate this combination is initiated.