Roche’s batch of phase 3 tests of its experimental GI drug etrolizumab has not gone to plan, with “mixed results” highlighting a murky picture for its ulcerative colitis (UC) program.
First, the positive readout: In the so-called HIBISCUS I induction study, in people without prior anti-TNF treatment, etrolizumab hit its primary endpoint. But the second HIBISCUS II induction study, which also included people without prior anti-TNF treatment, missed its endpoints.
And there’s more: In another test, known as the HICKORY study, which was in people with prior anti-TNF treatment, etrolizumab met the primary endpoint at induction, but not at maintenance.
And in a fourth test, known as the LAUREL maintenance study in people without prior anti-TNF treatment, etrolizumab once again failed to meet its primary endpoint.
Roche said it would release more data in time and that’s all it wrote on details. But this leaves a path forward difficult to light for the Big Pharma, and will make it a tougher sell to rival Takeda’s new UC drug Entyvio, an alpha-4 beta-7 integrin antibody.
Roche’s drug works as a dual-action anti-integrin antibody, a slightly different MOA to Entyvio’s, which is expected to make just over $1 billion by 2026, according to EvaluatePharma data, with etrolizumab forecast by the biopharma data company to be making a little less at $891 million.
Today’s data may be shrinking the possibility of hitting those figures for the Swiss major. Roche had planned to file this year, but made no mention of that in its PR Monday morning.
To its credit, Roche’s management were not trying to spin the data. “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., chief medical officer and head of global product development.
“We are fully analyzing 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 program ever undertaken in inflammatory bowel diseases, and we thank all the patients, investigators and healthcare professionals for their participation.”
It's certainly not curtains for the drug, and etrolizumab continues to be tested in a series of other tests, namely as an induction and maintenance treatment in people with moderately to severely active Crohn’s disease with and without prior anti-TNF treatment, as well as a safety test.
Roche did mention in its release that it was also investigating other GI meds from its pipeline.