Roche’s gut disease project etrolizumab provided a mixed bag of results this week, and chances of taking on Takeda’s Entyvio now look dead in the water. While details were scarce Roche said etrolizumab had beaten placebo in just two of three induction studies in ulcerative colitis, and failed in both maintenance trials. Beating placebo should have been the easy task, since several studies also pit it against anti-TNFs. Dominance over these now looks unlikely. Targeting beta-7 integrin is not new; Takeda’s Entyvio has been on the market since 2014, but Roche’s asset differs in that it targets a second integrin. Before the ulcerative colitis data analysts had pencilled in 2026 sales forecasts of $756m for etrolizumab, according to EvaluatePharma consensus, which will surely now be downgraded. Etrolizumab is also being tested in Crohn’s disease, but proving its worth now seems a lot harder.
| Newer mechanisms are set to dominate the ulcerative colitis market by 2026 | |||||
|---|---|---|---|---|---|
| Product | Company | Mechanism of Action | 2020e ($m) | 2026e ($m) | Indication status |
| Rinvoq | Abbvie | Jak1 inhibitor | - | 1,686 | Phase III |
| Stelara | Johnson & Johnson | IL-12 and IL-23 antibody | 298 | 1,314 | Marketed |
| Entyvio | Takeda | Alpha-4 beta-7 integrin antibody | 1,982 | 1,178 | Marketed (SC version filed) |
| Zeposia | Bristol Myers Squibb | S1P receptor 1 regulator; S1P receptor 5 regulator | - | 816 | Phase III |
| Etrolizumab | Roche | Alpha-4 beta-7 integrin antibody; alpha-E beta-7 integrin antibody |
- | 756* | Phase III |
| *Forecast before phase III data. Source: EvaluatePharma. | |||||
| Phase III studies of etrolizumab | |||
|---|---|---|---|
| Trial name | Details | Primary endpoint | Endpoint met? |
| Ulcerative colitis | |||
| Hibiscus I | TNF-naive, induction, incl Humira arm | Induction of remission vs placebo at wk 10 | Yes |
| Hibiscus II | TNF-naive, induction, incl Humira arm | Induction of remission vs placebo at wk 10 | No |
| Laurel | TNF-naive, maintenance, vs placebo | Remission at wk 62 | No |
| Hickory | Prior TNF failure, induction and maintenance, vs placebo | Induction: remission at wk 14 Maintenance: remission at wk 66 |
Induction: Yes Maintenance: No |
| Gardenia | TNF-naive, sustained remission, vs Remicade | Clinical response at wk 10 and remission at wk 54 | Primary completion was Apr |
| Cottonwood |
Open-label extension |
Long-term efficacy, adverse events | Data Aug 2025 |
| Crohn's disease | |||
| Bergamot | Induction and maintenance | Induction: remission, endoscopic improvement at wk 14 Maintenance: remission, endoscopic improvement at wk 66 |
Jun 2021 |
| Juniper | Open-label extension | Safety | Oct 2025 |
| Source: clinicaltrials.gov & Jefferies. | |||
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