ASH 2013: Meeting highlights from Novartis, Takeda, Biogen Idec and SOBI

10 December 2013

This year’s American Society of Hematology (ASH) meeting continued yesterday with more clinical trial results from some of the world’s biggest pharma and biotech companies. Data presented included:

Swiss drug major Novartis (NOVN: VX) announced that patients with myelofibrosis initially randomized to treatment with Jakavi (ruxolitinib) lived longer than those randomized to treatment with placebo or conventional therapy, as described in several analyses from the Phase III COMFORT-I and COMFORT-II studies. In the studies, Jakavi reduced the risk of death and maintained spleen reductions at three years compared to conventional therapy and placebo. Separate analysis showed Jakavi may increase the probability of 10-year survival of myelofibrosis patients by more than 50% compared to conventional therapy.
Seattle Genetics (Nasdaq: SGEN) and Japan’s largest drugmaker Takeda Pharmaceutical (TSE:4502) announced updated overall survival data from two Adcetris (brentuximab vedotin) pivotal Phase II clinical trials in relapsed/refractory Hodgkin lymphoma (R/R HL) and relapsed/refractory systemic anaplastic large cell lymphoma (R/R sALCL). Adcetris is an antibody-drug conjugate (ADC) directed to CD30. After a median observation time of 32.7 months from the first dose of Adcetris, median overall survival (OS) of 40.5 months was reported in R/R HL, and was not yet reached in R/R sALCL. Of the 34 patients who had a complete remission, the median OS had not yet been reached; the estimated three year survival rate was 54%.
US biotech firm Biogen Idec (Nasdaq: BIIB) and Swedish Orphan Biovitrum (STO: SOBI) announced new results from Phase III studies of their investigational long-lasting recombinant factor IX and VIII Fc fusion protein candidates for hemophilia B and A, rFIXFc (Alprolix) and rFVIIIFc (Eloctate), including an interim analysis of pediatric pharmacokinetics (PK) data. These interim data are the first to demonstrate that rFIXFc and rFVIIIFc have consistently prolonged half-lives in children, compared to study participants' prior therapies. Alprolix and Eloctate use a technology called Fc fusion and demonstrate prolonged circulation in the body, which has been shown in studies of adults with hemophilia to extend the time between prophylactic infusions.

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