Celgene announces updated analysis of data from Phase 2 JAKARTA2 clinical study
Celgene announced an updated analysis of data from the Phase 2 JAKARTA2 clinical study demonstrating clinically meaningful response rates with investigational fedratinib in patients with myelofibrosis previously treated with ruxolitinib. "This updated analysis of fedratinib employed intent-to-treat, or ITT, principles and utilized a narrower definition of ruxolitinib relapsed, refractory, or intolerant patients. Results were shared in a poster presentation today at the 2019 American Society of Clinical Oncology, or ASCO, Annual Meeting in Chicago. In the ITT population, the proportion of patients who exhibited a 35% or greater reduction in spleen volume at end of cycle 6 was 31%. Of these 97 patients, 79 met the narrower criteria for ruxolitinib resistance or intolerance. In this cohort, the proportion of patients who exhibited a 35% or greater reduction in spleen volume at end of cycle 6 was 30%, consistent with the response rate observed in the ITT population. In addition, the proportion of patients who exhibited a 50% or greater symptom response rate was 27% in both the ITT population and the patients in the analysis of the narrower criteria. The most common grade 3-4 hematologic abnormalities were anemia and thrombocytopenia. Most common non-hematologic treatment-emergent adverse events in all treated patients were diarrhea, nausea, vomiting, and constipation."