Brodalumab: Phase III data

The double-blind, international Phase III AMAGINE-3 trial in >1,800 patients with moderate to severe plaque psoriasis showed that 140 and 210 mg subcutaneous brodalumab every 2 weeks each met the co-primary endpoint of improving PASI 100 response rate at week 12 vs. Stelara ustekinumab. Both doses of brodalumab also met the co-primary endpoints of improving PASI 75 response rate and of a greater proportion of patients achieving an sPGA score of "clear" or "almost clear" at week 12 vs. placebo. Specifically, 27% of patients receiving low-dose brodalumab and 36.7% of patients receiving high-dose brodalumab achieved a PASI 100 response at week 12 vs. 18.5% of patients receiving Stelara and 0.3% of patients receiving placebo. Additionally, 69.2% of patients receiving low-dose brodalumab and 85.1% of patients receiving high-dose brodalumab achieved a PASI 75 response at week 12 vs. 69.3% of patients receiving Stelara and 6% of patients receiving placebo. The most common adverse events reported in the brodalumab arms were common cold, joint pain, upper respiratory tract infection and headache.

In May, the partners reported data from the Phase III AMAGINE-1 in the indication showing that brodalumab met the co-primary endpoints vs. placebo (see BioCentury, May 12). Data from the Phase III AMAGINE-2 trial of brodalumab to treat moderate to severe plaque psoriasis are expected by year end. Data from the Phase III AMVISION-1 and AMVISION-2 trials of brodalumab to treat psoriatic arthritis are expected in 2016 (see BioCentury, Aug. 11). The compound is also in Phase II testing for asthma. In 2012, Amgen and AstraZeneca partnered to jointly develop and commercialize 5 of Amgen's human mAbs in its inflammation portfolio, including brodalumab (see BioCentury, April 9, 2012). Kyowa has exclusive rights in Japan and other Asian countries to develop and commercialize brodalumab from Amgen. ...