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 thrombocytopenia rates were 38% and 22%, respectively. Patients with advanced MF substantially pretreated with ruxolitinib attained robust spleen responses and reduced symptom burden with fedratinib.
Original language | English |
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Pages (from-to) | 594-603 |
Number of pages | 10 |
Journal | American Journal of Hematology |
Volume | 95 |
Issue number | 6 |
DOIs | |
Publication status | Published - 1 Jun 2020 |
Keywords
- available therapy
- double-blind
- efficacy
- encephalopathy
- inhibitor fedratinib
- open-label
- outcomes
- phase-3
- safety
- sar302503
- EFFICACY
- SAFETY
- OPEN-LABEL
- PHASE-3
- ENCEPHALOPATHY
- DOUBLE-BLIND
- SAR302503
- OUTCOMES
- INHIBITOR FEDRATINIB
- AVAILABLE THERAPY