June 10, 2016
Novartis has announced Phase III data from RESPONSE-2 revealing that Jakavi®(ruxolitinib) assisted patients with polycythemia vera (PV), who were resistant to or intolerant of hydroxyurea and did not have an enlarged spleen, achieve superior hematocrit control compared to best available therapy (BAT) at 28 weeks (62.2% vs 18.7%, respectively; p<0.0001). These findings were presented at the 21st Congress of the European Hematology Association (EHA) in Copenhagen, Denmark for the first time.
Polycythemia vera is an incurable and rare blood cancer associated with an overproduction of blood cells causing serious cardiovascular problems, such as blood clots, stroke and heart attack. As the disease progresses, the spleen can become enlarged as it has to to clear a greater number of blood cells than normal. In this study, as assessed by physical examination at baseline, patients did not have an enlarged spleen (spleen palpation) and a majority (approximately 70%) were considered less advanced, as they were previously treated with hydroxyurea only. The remaining patients were treated with multiple lines of therapy (approximately 30%).
“RESPONSE-2 is the first study of this scale to focus on patients with inadequately controlled polycythemia vera in a less advanced phase of the disease. The study supports the use of Jakavi as a second-line treatment option to help this patient population gain better control of their disease,” said lead study investigator, Francesco Passamonti, MD, the University of Insubria, Varese, Italy.