Pivotal Ruxolitinib Data Shows Promise for Patients with PV

MILAN, June 13, 2014 /PRNewswire/ --

Dr Alessandro Vannucchi will present the promising results of a Phase III trial for polycythemia vera patients. 

Polycythemia vera (PV) is a chronic, incurable blood cancer with limited treatment options. If uncontrolled, PV can cause serious cardiovascular complications, such as stroke and heart attack. Patients with PV also face debilitating symptoms that can have a significant impact on their daily life. In the pivotal Phase III RESPONSE trial, 77% of patients treated with ruxolitinib achieved control of red cell numbers (without the need for phlebotomy) or spleen volume reduction of ≥35% compared to 20% of patients who were treated with best available therapy. A significantly greater proportion of patients achieved the composite primary endpoint of control of red cell numbers and spleen volume reduction when treated with ruxolitinib compared to best available therapy (21% compared to 1%, respectively; p< .0001). In the study, 49% of patients treated with ruxolitinib had a reduction by at least 50% of their PV symptom burden compared to 5% on best available therapy. Ruxolitinib was well tolerated and adverse events were consistent with those previously seen in ruxolitinib studies in PV and myelofibrosis.  With a high unmet need for new treatments, these findings reinforce the potential of ruxolitinib to become an important new option for patients with PV that is not adequately managed with existing therapies. In the study, best available therapy was defined as investigator selected monotherapy or observation only.

Presenter: Dr Alessandro Vannucchi

Affiliation: University of Florence, Florence, Italy

Topic: Pivotal Ruxolitinib Data Shows Promise for Patients with PV.

Abstract LB2436 will be presented by Dr Alessandro Vannucchi on Saturday June 14, 2014, 13:15 - 14:15 in Room Gold (SW - Level 2)

About the EHA Annual Congress 

Hematology is a specialty that covers everything to do with blood: its origin in the bone marrow, diseases of blood and their treatments. The latest data on research and developments will be presented. The topics range from stem cell physiology and development, to leukemia, lymphoma, myeloma - diagnosis and treatment; red blood cells -, white blood cells- and platelet disorders; thrombosis and bleeding disorders.