Vedolizumab: Additional Phase III data

Additional data from the double-blind, international Phase III GEMINI I trial showed that 47.1% of patients receiving vedolizumab in the blinded induction cohort (n=225) had a clinical response at week 6, a co-primary endpoint, vs. 25.5% for placebo (n=149; p<0.0001). Additionally, 44.8% and 41.8% of patients who responded to vedolizumab at week 6 (in either the blinded or open-label induction cohorts) and subsequently received vedolizumab every 4 (n=125) and 8 weeks (n=122), respectively, during the maintenance stage of the trial achieved clinical remission at week 52, also a co-primary endpoint, vs. 15.9% for placebo (n=126; p<0.0001 for both).

The trial enrolled 895 patients with moderately to severely active UC who have failed >=1 conventional therapy, including tumor necrosis factor (TNF) alpha antagonists. In the blinded induction cohort, 374 patients were randomized to receive vedolizumab or placebo at weeks 0, 2 and 6. Patients who responded to treatment were re-randomized to receive placebo or vedolizumab every 4 or 8 weeks for up to 46 weeks during the maintenance stage. In the open-label induction cohort, 521 patients received vedolizumab at weeks 0, 2 and 6 and patients who responded to treatment were randomized to receive placebo or vedolizumab every 4 or 8 weeks for up to 46 weeks during the maintenance stage. Patients have an option to continue treatment for up to 2 years in the open-label Phase III GEMINI LTS extension study. Data were presented at Digestive Disease Week meeting in San Diego. ...