Phase III readouts spell disaster for Genentech’s lead IBD drug
Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.
On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over 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 had anti-TNF therapy (i.e. the mega-blockbuster Humira); if it worked as a maintenance therapy for people who had never taken anti-TNF drugs; and if it worked as both an induction and a maintenance therapy for patients who had previously taken anti-TNF drugs.
In one 358-person trial of patients who had never taken anti-TNF drugs, etrolizumab was better than placebo at inducing remission. But in the second 358-person trial testing the same thing, it wasn’t. In the study that tested etrolizumab as a maintenance therapy, the experimental drug proved no better than placebo. And in the study that tested etrolizumab as a maintenance and induction therapy, etrolizumab was better than placebo at inducing remission but no better at sustaining remission.
The result was a hodgepodge of statistics that executives could only describe as disappointing.
“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 did not release the topline data, but said they will do so at future medical conferences. The safety results were consistent with previous studies, the company said.
The results won’t end the late-stage IBD program, even as it sets it back considerably. In addition to open-label expansion studies, the company is still running a pair of Phase III trials in Crohn’s disease.
Behind etrolizumab, Genentech has one other mid-stage asset for inflammatory diseases: An IL-22 fusion protein now in Phase II for IBD. By contrast, etrolizumab works as an integrin inhibitor similar to Takeda’s Entyvio.
The mixed bag is the second setback for Genentech in the past week, after the company’s checkpoint inhibitor Tecentriq failed in a triple-negative breast cancer study on Friday.