News
Mixed results from phase III trial of RG 7413 in ulcerative colitis.- Genentech/Roche
Genentech/Roche announced topline results from its Phase III study program evaluating the RG 7413 (etrolizumab) in people with moderately to severely active ulcerative colitis. Mixed results were seen in studies evaluating etrolizumab as an induction therapy, and both studies evaluating etrolizumab as a maintenance therapy failed to meet their primary endpoints, showing no significant difference in the proportion of people achieving remission with subcutaneous etrolizumab versus placebo. In the HIBISCUS I induction study, in people without prior anti-tumor necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint. In the HICKORY study, in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction but not at maintenance. In the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab failed to meet its primary endpoint. The safety profile of etrolizumab was consistent with previous studies and no major safety issues were identified in the four Phase III clinical trials reported to date. Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.Comment: Etrolizumab continues to be studied as an investigational induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global Phase III study (BERGAMOT) and open-label extension and safety monitoring study (JUNIPER), involving more than 1,100 people with Crohn’s disease. In addition, Genentech is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease.
Condition: Ulcerative Colitis
Type: drug