Etrolizumab’s novelty wears off

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

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: & Jefferies.

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