Amgen and AstraZeneca Report TEZSPIRE Eosinophilic Esophagitis Phase 3 CROSSING Results

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Company: Amgen

TEZSPIRE Eosinophilic Esophagitis data moved into the spotlight on October 20, 2026, when Amgen (NASDAQ: AMGN) and AstraZeneca announced full results from the positive Phase 3 CROSSING trial of TEZSPIRE (tezepelumab-ekko). The study enrolled adolescent and adult patients with symptomatic and uncontrolled eosinophilic esophagitis (EoE). It showed statistically significant, clinically meaningful improvements across co-primary and key secondary endpoints at week 24, and those improvements were sustained through week 52.

CROSSING evaluated TEZSPIRE at 210 mg and 420 mg, administered subcutaneously every four weeks. At week 24, histologic remission was achieved by 64.8% of patients on the 210 mg dose and 68.9% on the 420 mg dose, compared with 3.5% on placebo (p<0.001). Dysphagia, meaning difficulty swallowing, also improved on the patient-reported Dysphagia Symptom Questionnaire (DSQ), with reductions of 18.8 points and 22.0 points versus 14.7 points for placebo.

Full results will be presented in a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain. For readers following inflammation pipelines, the TEZSPIRE Eosinophilic Esophagitis readout adds a gastrointestinal dataset for a medicine whose current U.S. indications are in respiratory disease. The sections below cover trial design, efficacy, safety, disease background, and the Amgen–AstraZeneca collaboration.

TEZSPIRE Eosinophilic Esophagitis Trial Design and Co-Primary Endpoints

CROSSING was a randomized, double-blind, placebo-controlled, multi-center, parallel-group Phase 3 trial in patients aged 12 to 80 years with symptomatic and histologically active EoE. A total of 368 patients were randomized 1:1:1 to TEZSPIRE 210 mg, TEZSPIRE 420 mg, or placebo. The study is registered on ClinicalTrials.gov under NCT05583227.

The two co-primary endpoints, assessed at week 24, were histologic remission and mean change from baseline in DSQ score. Histologic remission was defined as a peak esophageal eosinophil count of six or fewer per high-power field, a measure obtained by examining esophageal biopsies under a microscope. The release notes that a count of 15 or more is often the cutoff used to diagnose EoE. The DSQ is a four-item daily diary, scored over 14-day periods from zero to 84, where higher scores indicate more severe dysphagia.

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Design choices matter for interpreting the TEZSPIRE Eosinophilic Esophagitis results. Patients could remain on background EoE medications, including proton pump inhibitors and swallowed topical corticosteroids, provided doses were stable before entry and during treatment. Investigator Arjan Bredenoord of Amsterdam University Medical Center highlighted that the benefits were seen even in that setting.

Week 24 and Week 52 Efficacy Data for TEZSPIRE Eosinophilic Esophagitis

On dysphagia at week 24, TEZSPIRE reduced DSQ scores by 18.8 points on the 210 mg dose (p=0.049) and 22.0 points on the 420 mg dose (p<0.001), compared with 14.7 points on placebo. The differences versus placebo were 4.1 and 7.3 points. The 210 mg result carried the narrower margin, with a 95% confidence interval of −8.1 to −0.0, so the two doses are best weighed separately.

Week 52 key secondary endpoints held the gains. Histologic remission was reported in 67.8% (210 mg) and 63.3% (420 mg) of TEZSPIRE patients versus 5.4% on placebo, both p<0.001. DSQ reductions reached 22.1 and 24.0 points versus 13.2 points for placebo, again p<0.001 for both doses. Taken together, the figures describe a TEZSPIRE Eosinophilic Esophagitis response that was sustained between week 24 and week 52.

Endoscopic results followed the same direction. On the EoE Endoscopic Reference Score (EREFS), which sums the severity of edema, rings, exudates, furrows, and strictures on a 0–18 scale, TEZSPIRE produced significant improvements at weeks 24 and 52. Total endoscopic remission, meaning no visible features of EoE, was achieved by 34.4% (210 mg) and 29.5% (420 mg) of patients at week 52, compared with 4.1% on placebo (p<0.001). The release states that a threshold for clinically meaningful EREFS improvement has not been established. Complete TEZSPIRE Eosinophilic Esophagitis figures appear in Tables 1 to 3 below.

Safety Profile and Disease Context Behind TEZSPIRE Eosinophilic Esophagitis Research

TEZSPIRE had a safety profile consistent with its approved indications. The most frequently reported adverse events in CROSSING were upper respiratory infection (nasopharyngitis), headache, and diarrhea. TEZSPIRE is currently indicated in the U.S. only as add-on maintenance treatment for severe asthma and for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 and older. Amgen states that EoE is an investigational use and that no conclusions about safety or effectiveness should be drawn for it.

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The prescribing information carries warnings that clinicians reading the TEZSPIRE Eosinophilic Esophagitis findings should keep in view. These include hypersensitivity reactions with postmarketing cases of anaphylaxis, treating pre-existing helminth infections before starting therapy, and avoiding live attenuated vaccines. Those warnings cover the approved indications, and the full Prescribing Information is linked from the release.

EoE is a chronic, progressive, epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the United States, with prevalence up five-fold since 2009. Symptoms, as described by MedlinePlus, include painful or difficult swallowing, food becoming stuck, nausea, and vomiting. Standard care relies on dietary restriction, proton pump inhibitors, and swallowed topical corticosteroids, yet nearly half of patients do not respond to standard first-line therapies or dietary treatment.

Evan Dellon, professor of medicine at the University of North Carolina School of Medicine and a trial primary investigator, described EoE as one of the fastest-growing chronic gastrointestinal conditions seen in clinics. He said once-every-four-weeks tezepelumab could be an important new option across symptomatic, histologic and endoscopic goals. Jay Bradner, Amgen’s executive vice president of Research and Development, Artificial Intelligence and Data, said a new approach is needed because half of patients remain uncontrolled on standard treatment.

Amgen–AstraZeneca Collaboration and What Comes Next for TEZSPIRE Eosinophilic Esophagitis

TEZSPIRE is a first-in-class human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine that sits at the top of multiple inflammatory cascades. Amgen says TSLP expression rises and correlates with disease severity across severe asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), and EoE. That mechanism explains why TEZSPIRE Eosinophilic Esophagitis development sits alongside COPD studies, including JOURNEY (NCT06878261) and EMBARK (NCT06883305).

Amgen collaborates with AstraZeneca on TEZSPIRE, with both companies sharing global costs, profits, and losses equally after AstraZeneca pays Amgen a mid-single-digit royalty. AstraZeneca leads global development and commercialization outside North America, while Amgen manufactures and supplies TEZSPIRE worldwide and recognizes U.S. product sales. AstraZeneca recognizes Canadian sales. TEZSPIRE is approved for severe asthma in the U.S., EU, China, Japan and more than 70 countries, and for CRSwNP in the U.S., EU, China and Japan.

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No regulatory submission timeline for EoE was disclosed in the release. Statements about potential new indications are preliminary and investigative, and Amgen’s forward-looking statements caution that clinical success cannot be guaranteed. Until regulators review the data, TEZSPIRE Eosinophilic Esophagitis remains an investigational use. Readers can verify every figure in the original Amgen press release, and the UEG Week 2026 presentation is the venue for the full dataset.

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