Takeda Announces Key Trial Data for ENTYVIO

Takeda announced data from the pivotal Phase 3 KEPLER trial, which demonstrated that ENTYVIO can offer the possibility of clinical remission for patients ages 2 and older with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the gastrointestinal tract and one of the two most common types of inflammatory bowel disease. The results, presented at the 21st Congress of the European Crohn's and Colitis Organisation, show vedolizumab's promising efficacy and safety profile in a patient population where therapy options remain limited. With KEPLER, Takeda is continuing to generate deeper scientific insights and identify additional patient populations who may benefit from vedolizumab, a cornerstone therapy for adults with ulcerative colitis. Vedolizumab is marketed under the trade name ENTYVIO. The KEPLER Phase 3 study included 120 children and adolescents 2 to 17 years-old with moderately to severely active UC who had an inadequate response to conventional treatments and/or tumor necrosis factor antagonists. Study participants received open-label intravenous vedolizumab during a 14 week open-label induction period.1 Ninety-three of 120 patients who achieved a clinical response at Week 14 were then randomized to low dose or high dose maintenance therapy with vedolizumab every 8 weeks. Of these 93 patients: Nearly half of participants achieved the primary endpoint of clinical remission at Week 54; More than one-third of patients achieved clinical remission at 14 weeks; and Greater than 1 in 4 participants attained the secondary endpoint of sustained clinical remission at both Weeks 14 and 54. Additionally, the safety profile of vedolizumab in trial participants was generally consistent with its established safety profile in adults, with no new safety signals identified. The most frequently occurring treatment-emergent adverse events reported with vedolizumab in the KEPLER study were upper respiratory infection, ulcerative colitis, and pyrexia. Takeda plans to submit marketing applications in the United States, the European Union and other markets for intravenous ENTYVIO for the treatment of moderately to severely active ulcerative colitis in children and adolescents ages 2-17.