New data from Phase III trial of Entyvio in Ulcerative Colitis and Crohn's - Takeda

Takeda Pharmaceuticals has announced that new data from GEMINI LTS (Long-Term Safety), a Phase III, ongoing, open-label extension study of Entyvio (vedolizumab) for the treatment of adults with moderately to severely active Ulcerative Colitis (UC) and Crohn's disease (CD). Patients who completed or withdrew early from the double-blind, randomized, placebo-controlled maintenance studies GEMINI 1 and 2 were eligible to enroll in GEMINI LTS. Patients included in the Efficacy Population (GEMINI completers) received vedolizumab 300 mg IV doses every four weeks (Q4W). Of the UC patients who completed GEMINI 1 and enrolled in GEMINI LTS, 66 percent were in clinical remission at week 52 and 73 percent were in clinical remission at week 104.

In addition, 79 percent had clinical response at week 52 and 80 percent had clinical response at week 104. Of the CD patients who completed GEMINI 2 and enrolled in GEMINI LTS, 57 percent were in clinical remission at week 52 and 61 percent were in clinical remission at week 104. In addition, 81 percent had clinical response at week 52 and 74 percent had clinical response at week 104. Although open-label, these data add to the evidence bank of vedolizumab, supporting the positive findings of the pivotal Phase III GEMINI 1 and 2 studies, which assessed the efficacy and safety of adult patients with moderately to severely active UC and CD, respectively, over 52 weeks. Data will be presented during the 21st United European Gastroenterology Week.