Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis.

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Presentation transcript:

Three-year efficacy, safety, and survival findings from COMFORT-II, a phase 3 study comparing ruxolitinib with best available therapy for myelofibrosis by Francisco Cervantes, Alessandro M. Vannucchi, Jean-Jacques Kiladjian, Haifa Kathrin Al-Ali, Andres Sirulnik, Viktoriya Stalbovskaya, Mari McQuitty, Deborah S. Hunter, Richard S. Levy, Francesco Passamonti, Tiziano Barbui, Giovanni Barosi, Claire N. Harrison, Laurent Knoops, and Heinz Gisslinger Blood Volume 122(25):4047-4053 December 12, 2013 ©2013 by American Society of Hematology

Mean percentage change in spleen volume over time. Mean percentage change in spleen volume over time. Assessments of changes in spleen volume in the BAT arm were determined based on the patients’ original baseline spleen volume and not from the time of crossover. Patients crossed over from the BAT arm to receive ruxolitinib over the course of approximately 6 to 8 months. Francisco Cervantes et al. Blood 2013;122:4047-4053 ©2013 by American Society of Hematology

Duration of spleen response. Duration of spleen response. Includes randomized and extension phases for patients randomized to ruxolitinib; crossover patients are not included. Duration of maintenance was estimated only for patients who achieved a ≥35% reduction in spleen volume. The start date was defined as the first spleen volume measurement that was a ≥35% reduction from baseline (minimum of 12 weeks [ie, first on-treatment assessment by magnetic resonance imaging]), and the end date was the first measurement that was no longer a ≥35% reduction and that was a >25% increase above the nadir. Francisco Cervantes et al. Blood 2013;122:4047-4053 ©2013 by American Society of Hematology

Hemoglobin levels and platelet counts over time. Hemoglobin levels and platelet counts over time. Ruxolitinib includes both the randomized and extension phases; BAT includes the randomized phase only and not the assessments after crossover. Francisco Cervantes et al. Blood 2013;122:4047-4053 ©2013 by American Society of Hematology

Kaplan-Meier analysis of overall survival in the COMFORT-II Trial. Kaplan-Meier analysis of overall survival in the COMFORT-II Trial. In this intention-to-treat analysis of overall survival, patients who crossed over from the BAT arm to receive ruxolitinib are included in the BAT group. Francisco Cervantes et al. Blood 2013;122:4047-4053 ©2013 by American Society of Hematology