PACIFICA study is a registration randomized Phase III study of patients with higher-risk myelofibrosis that are ruxolitinib treatment naïve, or at least have less than 90 days of prior JAK inhibitor therapy, with a baseline platelet count of less than 50,000.
This study randomizes patients to best available therapy, which is predetermined by the investigator, and can include low dose ruxolitinib, hydroxyurea, danazol, or prednisone, to pacritinib 200 milligrams twice daily...
PACIFICA study is a registration randomized Phase III study of patients with higher-risk myelofibrosis that are ruxolitinib treatment naïve, or at least have less than 90 days of prior JAK inhibitor therapy, with a baseline platelet count of less than 50,000.
This study randomizes patients to best available therapy, which is predetermined by the investigator, and can include low dose ruxolitinib, hydroxyurea, danazol, or prednisone, to pacritinib 200 milligrams twice daily. The primary endpoint is SVR 35% at 24 weeks. And a key secondary endpoint is total symptom score reduction. This is an important study to establish the benefit of pacritinib in this population with extreme thrombocytopenia, which represents an urgent unmet need. And this trial is ongoing.