Mixed results for etrolizumab in UC trial program
Etrolizumab, an investigational drug developed by Genentech, failed to meet the primary maintenance endpoints in several phase 3 trials and had mixed results in other induction studies, according to a company press release.
Researchers evaluated the drug, a dual anti-integrin that inhibits alpha4beta7 and alphaEbeta7, in a trial program comprising eight randomized-controlled trials, as well as two open-label extension and safety monitoring studies.
In the studies that explored the drug’s efficacy in inducing remission in patients with moderate to severe ulcerative colitis, etrolizumab met the primary endpoint in the HIBISCUS I study but did not in the HIBISCUS II study.
Moreover, the drug met the primary endpoint in the induction phase of the HICKORY study, but not in the maintenance phase. It also failed to reach the primary endpoint in the LAUREL maintenance study.
Investigators did not identify any major safety issues during any of the phase 3 trials.
“We are disappointed with these results, because we know that people with ulcerative colitis need new treatment options,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the press release. “We are fully analyzing these data to learn more about how we might address the needs of people with this devastating disease.”
Etrolizumab is also being studied as a treatment for patients with moderately to severely active Crohn’s disease.