RESPONSE trial success for Jakavi/Jakafi for Polycythemia Vera - Incyte + Novartis

Novartis announced results from the first-ever pivotal Phase III study evaluating a JAK 1/2 inhibitor for the treatment of Polycythemia Vera (PV). Jakavi (ruxolitinib) significantly improved hematocrit control without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells and reduced spleen size in patients with PV who are resistant to or intolerant of hydroxyurea. Findings are being presented at the 50th Annual Meeting of the American Society of Clinical Oncology in Chicago, Illinois.

At week 32 of the study, 77% of patients randomized to ruxolitinib achieved one or both components of the composite endpoint of hematocrit control (volume percentage of red blood cells in whole blood or spleen size reduction in comparison with 20% of patients randomized to best available therapy. A significantly greater proportion of patients achieved the composite primary endpoint when treated with ruxolitinib compared to best available therapy (21% compared to 1%, respectively; p<.0001), and 91 of these patients treated with ruxolitinib maintained their response at week 48.>

In the study, a 50% or more improvement in PV-related symptoms was seen in 49% of ruxolitinib-treated patients compared to 5% of patients treated with best available therapy. Patients treated with ruxolitinib also experienced a reduction in night sweats and itchiness (approximately 99% and 95%, respectively). In addition, a greater proportion of patients on the ruxolitinib treatment arm achieved complete hematologic response as defined by the modified 2009 European LeukemiaNet (ELN) criteria, a key secondary endpoint, when compared to the best available therapy arm (24% compared to 9%, respectively; p=.003).

See - Verstovsek S, et al. "Results of a prospective, randomized, open-label Phase III study of ruxolitinib in polycythemia vera patients resistant to or intolerant of hydroxyurea: The RESPONSE Trial." Abstract #7026. 50th American Society of Clinical Oncology (ASCO) Chicago, IL.

erstovsek S, et al. "Results of a prospective, randomized, open-label Phase III study of ruxolitinib in polycythemia vera patients resistant to or intolerant of hydroxyurea: The RESPONSE Trial." Abstract #7026. 50th American Society of Clinical Oncology (ASCO) Chicago, IL.