publication date: Mar. 31, 2015

Pacritinib Phase II Study Shows Reduction in Spleen Volume

 

A phase II study of pacritinib in patients with myelofibrosis demonstrated that pacritinib is active in patients with myelofibrosis, resulting in spleen volume reduction, while producing substantial and prolonged improvement in disease-related symptoms without causing clinically significant myelosuppression.

Researchers believe pacritinib is well tolerated, including in patients with disease-related anemia and thrombocytopenia, with the predominant side effect being manageable gastrointestinal toxicity.

Pacritinib is a next-generation oral JAK2/FLT3 multikinase inhibitor currently in phase III development in the PERSIST program. The study results were published in the journal Blood.

The multicenter, single-arm, open-label study evaluated the safety and efficacy of pacritinib in the treatment of patients with myelofibrosis who had clinical splenomegaly poorly controlled with standard therapies or were newly diagnosed with intermediate- or high-risk disease and not considered candidates for standard therapy. Patients were allowed to enroll irrespective of their degree of thrombocytopenia, anemia or neutropenia.

A total of 35 patients were enrolled and treated with pacritinib 400 mg administered once daily in 28-day cycles. The median age of the patients was 69 years.

The endpoint of the study was assessment of the spleen response rate, defined as the proportion of subjects achieving 35 percent or greater reduction in spleen volume from baseline up to week 24. Other endpoints included the proportion of patients with 50 percent or greater reduction in spleen size as determined by physical exam and the proportion of patients with 50 percent or greater reduction in total symptom score, including symptoms of abdominal pain, bone pain, early satiety, fatigue, inactivity, night sweats and pruritus, from baseline up to week 24.

Results showed that … Continue reading CCL March – Pacritinib Phase II Study Shows Reduction in Spleen Volume

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