New data presented at EHA meeting for Jakavi for treatment of myelofibrosis. -Novartis.

Novartis announced new findings at the 23rd Congress of the European Hematology Association (EHA) in Stockholm, Sweden. Jakavi data presented at the EHA Annual Congress includes efficacy and safety analyses of the largest expanded access trial of myelofibrosis (MF) patients treated with Jakavi to date (JUMP).

An efficacy analysis showed that patients with lower-risk MF achieved spleen size reductions when treated with Jakavi, with most patients (82.1%) achieving a >=50% reduction at any time. A separate analysis identified factors that may lead to a greater spleen response in patients with MF treated with Jakavi, including treating earlier in the course of the disease and at a higher dose (>=10 mg BID).

Additionally, 48-week data from the EXPAND study support Jakavi 10 mg BID as a starting dose in patients with MF with low platelet counts, providing important information in a patient population at an increased risk of bleeding and serious complications. Nearly one-third of patients in the study treated with Jakavi achieved a >=50% reduction in spleen size at week 48 (31.8% of patients [7/22] with a platelet count of 75 to 99 x 109/L and 35.7% [5/14] of patients with a platelet count of 50 to 74 x 109/L).

About the JUMP Study- JUMP is an expanded access Phase IIIb study designed to further evaluate the safety and efficacy of Jakavi in MF. It includes the largest cohort of patients with MF treated with Jakavi, 233, to date. The study provided access to Jakavi for patients who had no access to the treatment outside of a clinical trial and included 60 patients who were determined to have DIPSS low-risk disease.

About the EXPAND Study- EXPAND is an open-label, Phase Ib, dose-finding study in patients with MF with baseline platelet counts of 50 to 99 x 109/L. Results presented at EHA are from the 48-week follow- period. The study evaluated 10 mg BID as a safe starting dose of Jakavi. The key secondary endpoints are safety and efficacy, including proportion of patients achieving >=50% of reduction in spleen size. Safety findings were also consistent with previous studies of Jakavi.

See- Guglielmelli, et al. "Safety and Efficacy of Ruxolitinib (Rux) in Patients (Pts) with Dipss Low-Risk Myelofibrosis (MF) in the Phase IIIb Expanded-Access Jump Study". EHA 2018. Abstract PF623.

Gupta, et al." Predictors of Response to Ruxolitinib (Rux) in Patients (Pts) with Myelofibrosis (MF) in the Phase IIIb Expanded-Access Jump Study". EHA 2018. Abstract PF616.