Amgen and AstraZeneca's Tezspire holds EoE remission to one year in Phase 3 CROSSING

Amgen and AstraZeneca on 20 October released the full Phase 3 CROSSING results for Tezspire (tezepelumab) in eosinophilic esophagitis (EoE), showing the TSLP-blocking antibody met both co-primary endpoints at week 24 and held its effect to week 52 in adolescents and adults ¹. The data are due as a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona ¹.

What the trial found

CROSSING was randomised, double-blind and placebo-controlled, run across multiple centres, and enrolled 368 patients aged 12 to 80 with symptomatic, histologically active EoE ¹. Patients were split 1:1:1 between 210 mg and 420 mg of Tezspire, given under the skin every four weeks, and placebo ¹.

At week 24, histologic remission (a peak count of no more than six eosinophils per high-power field) was reached by 64.8% on the 210 mg dose and 68.9% on 420 mg, against 3.5% on placebo (p<0.001) ¹. The symptom co-primary, measured with the patient-reported Dysphagia Symptom Questionnaire (DSQ), was closer. Scores fell by 18.8 points on 210 mg and 22.0 points on 420 mg, compared with 14.7 points on placebo ¹. The lower dose cleared significance narrowly at p=0.049, with a difference of 4.1 points. The higher dose showed a 7.3 point gap at p<0.001 ¹.

The week 52 secondary endpoints moved in the same direction:

• histologic remission of 67.8% (210 mg) and 63.3% (420 mg), against 5.4% on placebo ¹

• DSQ reductions of 22.1 and 24.0 points, against 13.2 points on placebo, both p<0.001 ¹

• total endoscopic remission, with no visible features of EoE, in 34.4% and 29.5%, against 4.1% on placebo ¹

The 420 mg dose did not outperform 210 mg at one year on remission measures ¹. Patients could stay on stable background therapy, including proton pump inhibitors and swallowed topical corticosteroids ¹. The most common adverse events were nasopharyngitis, headache and diarrhoea, and the companies describe the safety profile as consistent with Tezspire's approved uses ¹.

What it means for the market

Tezspire is approved for severe asthma in the US, EU, China, Japan and more than 70 countries, and for inadequately controlled chronic rhinosinusitis with nasal polyps in the US, EU, China and Japan ¹. EoE would add a gastrointestinal indication to a respiratory franchise, and the companies also list COPD among the drug's development programmes ¹. Amgen's Jay Bradner said the companies "continue to study TEZSPIRE across epithelial-driven inflammatory diseases" ¹.

The commercial terms are shared. Amgen and AstraZeneca split global costs, profits and losses equally after AstraZeneca pays Amgen a mid-single-digit royalty ¹. AstraZeneca leads global development and commercialisation outside North America, while Amgen books US sales and manufactures and supplies the drug worldwide ¹.

The unmet need the release cites is broad. EoE affects more than 470,000 people in the US, prevalence has risen five-fold since 2009, and nearly half of patients do not respond to standard first-line or dietary treatment ¹. One of the trial's lead investigators, Evan Dellon of the University of North Carolina, said dosing "once every four weeks" would make tezepelumab "an important new treatment option" ¹. The release does not give a timetable for regulatory filings in EoE.

Caveats

These are company-reported results that have not yet been through peer review ¹. The symptom benefit on the 210 mg dose at week 24 was modest and only just significant. The release also notes that no threshold has been set for what counts as a clinically meaningful change in the endoscopic EREFS score, one of the key secondary measures ¹.