Roche posts mixed results on phase III studies of etrolizumab in ulcerative colitis
Basel: Roche has announced topline results from its phase III study programme evaluating the investigational medicine etrolizumab in people with moderately to severely active ulcerative colitis.
Mixed results were seen in studies evaluating etrolizumab as 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-tumour 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.
"We are disappointed with these results because we know that people with ulcerative colitis need new treatment options," said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. "We are fully analysing these data to learn more about how we might address the needs of people with this devastating disease. These studies were part of the largest clinical trial programme ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation."
Further analyses of the data, including secondary endpoints, are ongoing and will be submitted for presentation at upcoming medical meetings.
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, Roche is studying other investigational medicines in inflammatory bowel diseases and is committed to further understanding this disease.
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