Roche’s entrolizumab disappoints at Phase 3 in moderately to severely active ulcerative colitis

pharmafile | August 11, 2020 | News story | Manufacturing and Production, Research and Development Roche, etrolizumab, trial failure, ulcerative colitis 

Roche has voiced its disappointment after its investigational therapy etrolizumab showed “mixed results” as a treatment for moderately to severely active ulcerative colitis at Phase 3, falling short of its main goal in a number of studies.

The therapy met its primary endpoint in an induction study of participants who had not previously received anti-tumour necrosis factor (anti-TNF) treatment, but failed in a second identical study.

Then, in a study of patients who had previously undergone anti-TNF treatment, etrolizumab passed at the induction stage but not the maintenance stage, while it failed to meet its main goal in another study of participants without prior anti-TNF treatment.

“We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” said Dr Levi Garraway, 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.”

Despite this latest hurdle, Roche is still pushing the drug forward for patients with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment in a global Phase 3 study of over 1,000 participants.

Matt Fellows

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