Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: An updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure.

American Journal of Hematology
Claire N HarrisonRuben A Mesa

Abstract

Fedratinib is an oral, selective Janus kinase 2 (JAK2) inhibitor. The phase II JAKARTA2 study assessed fedratinib in patients with intermediate- or high-risk myelofibrosis (MF) who were resistant or intolerant to prior ruxolitinib per investigator assessment. Patients received fedratinib 400 mg/day in 28-day cycles. The JAKARTA2 outcomes were initially reported using a last-observation-carried forward (LOCF) analysis in a "Per Protocol" population. This updated analysis of JAKARTA2 employs intention-to-treat analysis principles without LOCF for all treated patients (ITT Population; N = 97), and for a patient subgroup who met more stringent definitions of prior ruxolitinib failure (Stringent Criteria Cohort; n = 79). Median duration of prior ruxolitinib exposure was 10.7 months. The primary endpoint was spleen volume response rate (SVRR; ≥35% spleen volume decrease from baseline to end of cycle 6 [EOC6]). The SVRR was 31% in the ITT Population and 30% in the Stringent Criteria Cohort. Median duration of spleen volume response was not reached. Symptom response rate (≥50% reduction from baseline to EOC6 in total symptom score [TSS] on the modified Myelofibrosis Symptom Assessment Form [MFSAF]) was 27%. Grade 3-4 anemia and thrombo...Continue Reading

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Citations

Mar 22, 2020·Annals of Hematology·Claire N HarrisonRuben A Mesa
Sep 10, 2020·HemaSphere·Prithviraj Bose, Srdan Verstovsek
Apr 17, 2020·Leukemia & Lymphoma·Prithviraj Bose, Srdan Verstovsek
Nov 17, 2020·American Journal of Hematology·Ayalew Tefferi
Dec 18, 2020·Expert Opinion on Drug Safety·Giacomo Coltro, Alessandro M Vannucchi
Dec 4, 2020·Journal of Hematology & Oncology·Sangeetha Venugopal, John Mascarenhas
May 22, 2021·Cancer Chemotherapy and Pharmacology·Ken OgasawaraGopal Krishna
Jul 18, 2021·Clinical Lymphoma, Myeloma & Leukemia·Prithviraj Bose, Srdan Verstovsek
Aug 28, 2021·Cancers·Dana C BorcherdingAngela C Hirbe
Aug 30, 2021·Lancet·Donal P McLornanClaire N Harrison
Aug 31, 2021·OncoTargets and Therapy·Julian A WaksalJohn Mascarenhas
Nov 16, 2021·Leukemia & Lymphoma·Prithviraj Bose, Ruben A Mesa

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Clinical Trials Mentioned

NCT01523171
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NCT03952039
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Dynamic International Prognostic Scoring System Plus ( DIPSS ‐...

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