Roche announces 'disappointing' results from etrolizumab trials
Roche announced topline results from its phase 3 study programme evaluating the investigational medicine ‘etrolizumab’ in people with moderately-to-severely active ulcerative colitis on Monday.
The Swiss drugmaker said mixed results were seen in studies evaluating etrolizumab as an induction therapy, while 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 when compared to placebo.
In the ‘HIBISCUS I’ induction study, in people without prior anti-tumour necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint.
By 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, while 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 3 clinical trials reported to date.
“We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Roche’s chief medical officer and head of global product development Levi Garraway.
“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.”
Roche said further analyses of the data, including secondary endpoints, were ongoing, and would be submitted for presentation at upcoming medical meetings.
Etrolizumab was still being 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 3 study titled ‘BERGAMOT’, and an open-label extension and safety monitoring study dubbed ‘JUNIPER’, involving more than 1,100 people with Crohn’s disease.
In addition, Roche said it was studying other investigational medicines in inflammatory bowel diseases, and was “committed to further understanding” the disease.