Roche had big plans for etrolizumab. In view of a hypercompetitive IBD and the Crohn’s market, where they have historically not been a player, the company rolled out 8 different Phase III studies, testing the antibody for two different uses in a variety of different patient groups.
On Monday, Roche published results for 4 of those studies, and they mark a definite backlog for both the Swiss pharma and its biotech sub Genentech, potentially playing an end to a drug they put more than half a decade and millions of dollars behind.
The four studies examined etrolizumab as a treatment for ulcerative colitis, testing to see if it worked as an induction treatment for patients who had never received anti-TNF therapy (ie the mega-blockbuster Humira); if it worked as maintenance therapy for people who had never taken anti-TNF medication; and if it worked as both an induction and a maintenance therapy for patients who hie previously taken anti-TNF drugs.
In one trial of 358 subjects from patients who had never taken anti-TNF medication, etrolizumab was superior to placebo in inducing remission. But in the second trial of 358 people testing the same thing, it was not. In the study testing etrolizumab as maintenance therapy, the experimental drug proved no better than placebo. And in the study that tested etrolizumab as maintenance and induction therapy, etrolizumab was better than placebo in inducing remission, but not better in maintaining remission.
The result was a hodgepodge of statistics that performers could only describe as disappointing.
Levi Garraway“We are disappointed with these results because we know that people with ulcerative colitis need new treatment options,” CMO Levi Garraway said in a statement.
Genentech has not released the topline data, but said it will do so at future medical conferences. The safety results were consistent with previous investigations, the company said.
The results will not end the IBD program in the late stages, even though it puts it back completely. In addition to open-label expansion investigations, the company is still running a few phase III tears in Crohn’s disease.
Behind etrolizumab, Genentech has another mid-phase asset for inflammatory diseases: An IL-22 fusion protein now in Phase II for IBD. When controlled, etrolizumab acts as an integrin inhibitor similar to Takeda’s Entyvio.
The mixed bag is the second deployment for Genentech in the past week, after the company’s checkpoint inhibitor Tecentriq failed in a triple-negative breast cancer study on Friday.
