Roche provides update on phase III studies of etrolizumab in people with moderately to severely active ulcerative colitis

• Etrolizumab met its primary endpoint of inducing remission versus placebo for people with ulcerative colitis in only two of three studies
• Etrolizumab failed to meet its primary endpoint versus placebo as maintenance therapy in people with ulcerative colitis
• Analyses of these data are ongoing to better understand the results
• Pivotal phase III study of etrolizumab in Crohn’s disease is ongoing
• Roche is studying additional investigational medicines in inflammatory bowel diseases
  
  

Basel, 10 August 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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 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-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.”