1:40AM Incyte reports additional analyses of symptomatic improvement and quality of life with Ruxolitinib in patients with myelofibrosis from the COMFORT-I study (INCY) 17.57 : Co announces additional symptom improvement and quality of life results from COMFORT-I, a randomized, double-blinded, placebo-controlled Phase III trial of Incyte's JAK1 and JAK2 inhibitor, ruxolitinib, in patients with myelofibrosis. The data demonstrated that treatment with ruxolitinib resulted in significant reductions in spleen volume and improvements in Total Symptom Score while placebo-treated patients experienced progressive splenomegaly and worsening of symptoms. These data demonstrated that the primary endpoint of a 35% reduction in spleen volume was clearly associated with reduction of abdominal symptoms associated with an enlarged spleen. Importantly, many patients with less than 35% reduction in spleen volume also had meaningful improvement in abdominal symptoms. In addition, of patients who had a 50% or greater reduction in TSS (a key secondary endpoint), nearly 90% rated their disease as "much or very much improved" based on the PGIC scale. Also, over 50% of patients with a 25% to 50% TSS improvement rated their disease as "much or very much improved," indicating that a significant proportion of these ruxolitinib-treated patients also had meaningful improvement in their disease. Associated with these improvements were improvements in almost all sub-scales of the European Organization for Research and Treatment of Cancer Quality-of-Life 30 Questionnaire, a standard and well-validated measure of quality of life in cancer patients.
surf's up......crikey
