Zinbryta daclizumab high-yield process: Additional Phase III data

Additional data from the double-blind, international Phase III DECIDE trial in more than 1,800 RRMS patients showed that once-monthly 150 mg subcutaneous Zinbryta for 96-144 weeks met the secondary endpoint of improving the proportion of patients who were relapse free at week 96 vs. once-weekly 30 ug intramuscular Avonex interferon beta-1a (73% vs. 59%, p<0.0001). Zinbryta also met the secondary endpoint of reducing the risk of meaningful worsening in the physical impact of MS (>7.5 point worsening in the MSIS-29 physical score) vs. Avonex (24% reduction compared to Avonex, p=0.018). On tertiary endpoints, Zinbryta led to a 27% reduction in the risk of 6-month sustained disability progression (p=0.03); a 65% reduction in the mean number of gadolinium-enhancing lesions at week 96 (p<0.0001); and a 52% reduction in the mean number of T1 hypointense lesions at week 96 (p<0.0001) vs. Avonex. Data were presented at the Joint ACTRIMS-ECTRIMS meeting in Boston. All patients completing DECIDE have the option to enroll in the open-label EXTEND extension study of Zinbryta.

Earlier this year, Biogen Idec reported top-line data from DECIDE showing that Zinbryta met the primary endpoint of reducing ARR and the secondary endpoint of reducing the number of new or newly enlarging T2 hyperintense lesions from baseline to week 96 vs. Avonex (see BioCentury, June 23). In 2011, Biogen Idec reported top-line data from the Phase IIb SELECT trial in 600 RRMS patients showing that once-monthly 150 and 300 mg Zinbryta each met the primary endpoint of reducing ARR vs. placebo (see BioCentury, Aug. 15, 2011 & Oct. 29, 2012). Biogen Idec and partner AbbVie plan to submit regulatory applications for Zinbryta to treat RRMS in 1H15. ...