Highlights of EHA meeting: Novartis' Jakavi; Bristol-Myers and AbbVie's elotuzumab; Janssen's ibrutinib

16 June 2013

Among presentations over the weekend at the Congress of European Hematology Association (EHA) being held in Stockholm, Sweden, Swiss drug major Novartis (NOVN: VX) announced results from a Phase III three-year follow-up study that showed Jakavi (ruxolitinib) demonstrated improved overall survival and sustained reductions in spleen size compared to conventional therapy. Jakafi, an oral JAK1 and JAK2 inhibitor, is licenses from USA-based Incyte (Nasdaq: INCY) and is cleared for marketing in the USA and Europe under the trade names Jakavi and Jakafi.

A 52% reduction in risk of death was observed in the Jakavi arm compared with conventional therapy (HR=0.48; 95% CI, 0.28-0.85; p=0.009), and the estimated probability of overall survival was significantly greater with Jakavi compared to conventional therapy (81% compared to 61%, respectively) at 144 weeks. Additionally, 51.4% of patients treated with Jakavi achieved a >=35% reduction from baseline in spleen size. Patients continue to maintain their spleen response, with the median spleen reduction not yet reached in the study new three-year COMFORT-II study data.

Data were also presented from an exploratory analysis of bone marrow morphology from a separate Phase I/II trial of Jakavi, compared with historical controls from patients treated with conventional therapy. After four years of Jakavi therapy, bone marrow fibrosis improved in 22% and stabilized in 56% of patients with myelofibrosis. A comparable effect was not seen with long-term conventional therapy.

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