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VIDEO: PERSIST-2 offers more insight into risk–benefit ratio of pacritinib for myelofibrosis
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SAN DIEGO — Aaron T. Gerds, MD, spoke with HemOnc Today about results of the PERSIST-2 trial, presented at the ASH Annual Meeting and Exposition.
Gerds and colleagues conducted a randomized controlled phase 3 trial to compare the investigational tyrosine kinase inhibitor pacritinib (CTI BioPharma) with best-available therapy in 311 patients with myelofibrosis. All patients had platelet counts less than 100,000 µl.
The percentages of patients who achieved at least 35% spleen volume reduction and at least 50% reduction in total symptom score from baseline to week 24 served as co-primary endpoints.
Researchers randomly assigned patients 1:1:1 to receive 200 mg of pacritinib twice daily, 400 mg of pacritinib daily, or best available therapy. Best available therapy could include the JAK1/JAK2 inhibitor ruxolitinib (Jakafi, Incyte).
Patients in both pacritinib arms achieved superior spleen reduction volume compared with best available therapy; however, twice-daily dosage appeared more active.
The FDA placed pacritinib on a full clinical hold in February. From a patient perspective, these results are important, Gerds said.
“This study adds more safety data to the PERSIST-1 study and the earlier-phase studies,” Gerds said. “By putting this all together and pooling it, we’ll get a better sense of the risk–benefit ratio for patients, and whether this medication should move forward and be made available for the patients who desperately need this treatment.” – by Kristie L. Kahl
Reference:
Mascarenhas J, et al. Abstract LBA-5. Presented at: ASH Annual Meeting and Exposition; Dec. 3-6, 2016; San Diego.
Disclosures: Gerds reports research funding from AstraZeneca, CTI BioPharma, Incyte and Roche.