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Researchers Present Status of PACIFICA Trial for Treatment of Primary or Secondary Myelofibrosis and Severe Thrombocytopenia
At the 64th ASH Annual Meeting, researchers provided information about the multinational, multicenter, randomized, controlled Phase III PACIFICA trial. This trial is currently in the recruiting stage and aims to gather data to validate the efficacy and safety of the oral JAK2/IRAK1/ACVR1 inhibitor pacritinib 200 mg twice a day vs the prescriber’s selection therapy in patients with myelofibrosis and severe thrombocytopenia (as defined as platelet count <50,000 uL).
In the trial, patients were randomized 2:1 to receive continuous pacritinib 200 milligrams twice daily or prescriber's choice low dose- ruxolitinib [no more than 10 milligrams per day] as well as danazol, corticosteroids or hydroxyurea.
Due to recommendations from regulatory agencies, the trial was restructured to include co-primary endpoints: spleen volume reduction and total symptom score.
The co- primary endpoints are the percentage of patients reaching a greater than or equal to 35% spleen volume reduction and the percentage reaching a decrease of 50% or more in adjusted total symptom score from baseline at week 24.
Presenter John Mascarenhas, MD, Department of Hematology and Medical Oncology, Icahn School of Medicine at mount Sinai, New York, NY, indicated that, “To account for co primary endpoints the sample size was adjusted from 348 to 399 patients to provide 80% power to detect difference between pacritinib and physician's choice,” adding, “The secondary objectives include Patient Global Impression of Change response at week 24 overall survival and safety.”
Presenters also indicated that the tertiary endpoints are comprised of: “improvement in hematologic profile, leukemia-free survival, enhancement in level of fatigue, shifts in biomarkers and gene expression and the percentage of patients who experience a major adverse cardiac event.”
Currently, researchers conducting the PACIFICA are recruiting study participants outside of the United States at more than 100 sites globally. According to the Clinical Trials government website, the estimated study completion date is December 31, 2025.
Source: Mascarenhas J, Gerds A, Kiladjian J, et al. PACIFICA: A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients with Primary or Secondary Myelofibrosis and Severe Thrombocytopenia. Presented at 64th ASH Annual Meeting and Exposition. December 12, 2022. New Orleans, Louisiana. Abstract: 4316.
