TEZSPIRE® DELIVERED HISTOLOGIC REMISSION AND SYMPTOM IMPROVEMENT IN EOSINOPHILIC ESOPHAGITIS

Symptom Improvements Versus Placebo at Week 24 Were Sustained Through Week 52

Statistically Significant Total Endoscopic Remission with No Visible Inflammation or Fibrosis Attained Versus Placebo at Week 52

THOUSAND OAKS, Calif., Oct. 20, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced full results from the positive Phase 3 CROSSING trial that showed TEZSPIRE^® (tezepelumab-ekko) demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52 in adolescent and adult patients with symptomatic and uncontrolled eosinophilic esophagitis (EoE).^1,2 

CROSSING evaluated TEZSPIRE 210 mg and 420 mg administered subcutaneously every four weeks. Treatment with TEZSPIRE achieved histologic remission for 64.8% (210 mg dose) and 68.9% (420 mg dose) of patients at week 24, compared to 3.5% of patients on placebo (p<0.001). TEZSPIRE also reduced the frequency and severity of dysphagia symptoms (difficulty swallowing) by 18.8 points (210 mg dose; p=0.049) and 22.0 points (420 mg dose, p<0.001) from baseline vs. 14.7 points on placebo, as measured by the Dysphagia Symptom Questionnaire (DSQ) score, a patient-reported outcome measure.¹

These results were sustained through week 52, as assessed in key secondary endpoints. Histologic remission was achieved in 67.8% (210 mg dose) and 63.3% (420 mg dose) of patients receiving TEZSPIRE, compared with 5.4% receiving placebo (both p<0.001). Continued symptom improvements in DSQ scores were observed with 22.1 point (210 mg dose) and 24.0 point (420 mg dose) average reductions from baseline, compared with 13.2 points for placebo (both p<0.001).¹ See Tables 1-2 for detailed results across both doses.

"A new treatment approach is needed for people living with eosinophilic esophagitis, half of whom continue to experience uncontrolled symptoms despite standard treatment," said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. "We're pleased with the statistically significant and clinically meaningful, sustained improvements seen in CROSSING. As we continue to study TEZSPIRE across epithelial-driven inflammatory diseases, our focus remains on translating the science behind TSLP inhibition into meaningful outcomes for patients."

In additional key secondary endpoints, treatment with TEZSPIRE resulted in statistically significant improvements in endoscopic features and severity (measured with the EoE Endoscopic Reference Score, or "EREFS") at weeks 24 and 52. 34.4% (210 mg dose) and 29.5% (420 mg dose) of patients achieved total endoscopic remission with TEZSPIRE, meaning no visible features of EoE at week 52 (vs. 4.1% placebo (p<0.001)), as measured in a key secondary endpoint.¹ See Table 2.

Results from the CROSSING trial will be presented in a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain.

In patients with EoE, inflammation of the esophagus can lead to dysphagia, food impaction and esophageal narrowing, and the risk of food moving slowly or becoming stuck can make daily meals difficult and stressful. ^3,4 Nearly half of patients, including adolescents, do not achieve adequate disease control with current standard of care designed to manage symptoms, which include dietary restriction, swallowed topical corticosteroids and proton pump inhibitors.^5-7

"The prevalence of eosinophilic esophagitis is on the rise and has become one of the fastest-growing chronic gastrointestinal conditions we see in the clinic. This disease can severely impede a person's ability to eat and swallow, with many patients experiencing near-daily burden from the risk of food becoming stuck during meals," said Evan Dellon, M.D., professor of medicine and adjunct professor of epidemiology at the University of North Carolina School of Medicine, and primary investigator in the trial. "The CROSSING data suggest that tezepelumab, dosed once every four weeks, would be an important new treatment option to address key treatment goals in EoE across symptomatic, histologic and endoscopic outcomes."

"The CROSSING trial results are compelling because they show consistent, lasting improvements across three key measures of eosinophilic esophagitis — histologic remission, frequency and severity of dysphagia, and endoscopic remission — sustained through 52 weeks," said Arjan Bredenoord, M.D., gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, the Netherlands, and primary investigator in the trial. "Importantly, these meaningful results were seen even in patients who were allowed to remain on their stable background therapy."

In the trial, patients were allowed to remain on background medications for EoE, including proton pump inhibitors and swallowed topical corticosteroids, provided they were stable prior to entry and during the treatment period.² 

TEZSPIRE had a safety profile consistent with its approved indications. The most frequently reported adverse events for TEZSPIRE in the CROSSING trial were upper respiratory infection (nasopharyngitis), headache and diarrhea.¹

Table 1: Summary of co-primary efficacy endpoints*¹

*The first co-primary endpoint, histologic remission, was defined as having a peak eosinophil count ≤6 per high power field in the esophageal tissue. The second co-primary endpoint, the frequency and severity of dysphagia, was assessed using the patient-reported DSQ and measured as a mean change from baseline in DSQ score.

Table 2: Summary of key secondary endpoints¹

* The EREFS total score (0–18) is calculated by summing the scores from the proximal and distal esophagus, assessing the severity of five endoscopic features of EoE: edema, rings, exudates, furrows and strictures. Higher scores indicate more extensive disease.
** Total endoscopic remission is defined as a maximum EREFS score of 0 (on a 0–9 scale) across all esophageal levels (proximal, mid and distal), indicating the absence of all five assessed endoscopic features of EoE.

TEZSPIRE^® (tezepelumab-ekko) U.S. Indication

TEZSPIRE is indicated for:

• the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
• the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

TEZSPIRE^® (tezepelumab-ekko) Important Safety Information

CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 3%) are:

• Asthma: pharyngitis, arthralgia, and back pain.
• Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia.

USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please see the full Prescribing Information including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products by clicking here.

About TEZSPIRE^® (tezepelumab-ekko)

TEZSPIRE is a first-in-class human monoclonal antibody that works on a primary source of inflammation: the airway and gut epithelia, which are the first points of contact for many viruses, allergens, pollutants and other environmental triggers and insults. Specifically, TEZSPIRE targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of epithelial-driven inflammation associated with severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).^2,8-11

TSLP is released by the epithelium in response to inhaled or swallowed environmental inflammatory triggers. Across these disease states, the expression of TSLP is increased and correlates with disease severity.^8-12

TEZSPIRE is currently approved for the treatment of severe asthma in the U.S., EU, China, Japan and more than 70 countries across the globe, and for the treatment of inadequately controlled CRSwNP in the U.S., EU, China and Japan.

Beyond severe asthma and CRSwNP, TEZSPIRE is also in development for other potential indications including COPD and EoE.^13-15

About Eosinophilic Esophagitis (EoE)

EoE is a chronic and progressive epithelial-driven inflammatory disorder of the esophagus affecting more than 470,000 people in the US, with the prevalence increasing five-fold since 2009.^3,16 It is characterized by inflammation, remodeling and esophageal epithelial dysfunction.³ Epithelial dysfunction and inflammation are important characteristics of EoE and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment.³

The most common symptoms of EoE include difficulty and pain swallowing, food becoming stuck in the esophagus (which may require emergency medical interventions), nausea and vomiting.^16-18 Many patients, including adolescents, report challenges with swallowing and eating, including concerns about choking.^19,20

Patients are often treated with proton pump inhibitors or swallowed topical corticosteroids to manage inflammation.^3,5 Nearly half of patients with EoE will not respond to standard first-line therapies or dietary treatment.^6,7

About the Phase 3 CROSSING Trial

CROSSING was a randomized, double-blind, placebo-controlled, multi-center, parallel-group, Phase 3 trial designed to evaluate the efficacy and safety of TEZSPIRE administered subcutaneously every four weeks, compared to placebo in patients aged 12-80 years with symptomatic and histologically active EoE.² A total of 368 patients were randomized in a 1:1:1 ratio to receive either a 210 mg or 420 mg dose of TEZSPIRE or placebo.²

The co-primary endpoints analyzed at week 24 were the proportion of patients with histologic remission, defined as a peak esophageal eosinophil count less than or equal to six eosinophils per high-power field, and mean changes from baseline in the Dysphagia Symptom Questionnaire (DSQ).² The peak eosinophil count is obtained when biopsies of the tissue of the esophagus are examined under a microscope.² A count of 15 or more peak eosinophils per high power microscopic field measured by esophageal biopsy is often the cutoff used to diagnose EoE.^21,22 The DSQ captures the presence and severity of dysphagia symptoms in a daily diary with a four-item patient-reported questionnaire; the score is calculated over 14-day periods, ranging from zero to 84, with a higher score indicating more severe dysphagia.²

Key secondary endpoints assessed histologic remission and dysphagia symptoms at week 52; changes in endoscopic disease features (EREFS) and histologic severity and extent (EoE-HSS) at weeks 24 and 52; as well as endoscopic response, inflammatory remission and total endoscopic remission at week 52.² EREFS is a standardized scoring system used to assess five visible features of EOE in the esophagus during endoscopy: swelling (edema), rings, white patches (exudates), furrows and narrowing (strictures) where a higher score indicates more severe endoscopic disease.²³ A threshold for clinically meaningful improvements in EREFS change from baseline has not been established.

In the trial, patients were allowed to remain on background medications for EoE, including proton pump inhibitors and swallowed topical corticosteroids, provided that they were stable prior to entry and during the treatment period.²

About the Amgen and AstraZeneca Collaboration

Amgen is in a collaboration with AstraZeneca for the development and commercialization of TEZSPIRE. Under the collaboration, both companies share global costs, profits and losses equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca leads global development. In North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada. AstraZeneca leads commercialization for TEZSPIRE outside North America. Amgen manufactures and supplies TEZSPIRE worldwide.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average® and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.

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CONTACT: Amgen, Thousand Oaks
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REFERENCES

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2. ClinicalTrials.gov. Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis (CROSSING). Available at: https://clinicaltrials.gov/study/NCT05583227. [Last accessed October 2026].
3. Biedermann L. & Straumann A. Mechanisms and clinical management of eosinophilic oesophagitis: an overview. Nature Reviews Gastroenterol & Hepatol. 2023;20(2):101-119.
4. Ho CN, et al. Patient experience with eosinophilic esophagitis symptoms and impacts on daily life based on in-trial qualitative interviews. J Patient Rep Outcomes. 2025;9(1):3.
5. Hirano I, et al. AGA Institute and the Joint Task Force on Allergy-Immunology Practice Parameters clinical guidelines for the management of eosinophilic esophagitis. Gastroenterology. 2020;158(6):1776-1786.
6. Strauss AL, Falk GW. Refractory eosinophilic esophagitis: what to do when the patient has not responded to proton pump inhibitors, steroids and diet. Curr Opin Gastroenterol. 2022;38(4):395-401.
7. Lucendo AJ, et al. Efficacy of proton pump inhibitor drugs for inducing clinical and histologic remission in patients with symptomatic esophageal eosinophilia: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2016; 14(1):13-22.e1.
8. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.
9. Ying, S, et al. Thymic stromal lymphopoietin expression is increased in asthmatic airways and correlates with expression of Th2-attracting chemokines and disease severity. J Immunol 2005;174:8183-8190.
10. Calderon AA, et al. Targeting interleukin-33 and thymic stromal lymphopoietin pathways for novel pulmonary therapeutics in asthma and COPD. Eur Respir Rev. 2023;32(167):220144.
11. Nagarkar DR, et al. Thymic stromal lymphopoietin activity is increased in nasal polyps of patients with chronic rhinosinusitis. J Allergy Clin Immunol. 2013;132(3):593-600.e12.
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13. ClinicalTrials.gov. A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007) (JOURNEY). Available at: https://clinicaltrials.gov/study/NCT06878261. [Last accessed October 2026].
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15. ClinicalTrials.gov. Tezepelumab COPD Exacerbation Study (COURSE). Available at: https://clinicaltrials.gov/ct2/show/NCT04039113. [Last accessed: October 2026].
16. Thel HL, et al. Prevalence and costs of eosinophilic esophagitis in the United States. Clin Gastroenterol Hepatol. 2025;23(2):272-280.e8.
17. Gold BD, et al. Health-Related Quality of Life and Perceived Stigma in Eosinophilic Esophagitis: A Real-World, US, Web-Based Survey. Gastro Hep Adv. 2024;3(8):1087-97.
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19. Taft TH, et al. Anxiety and depression in eosinophilic esophagitis: a scoping review and recommendations for future research. J Asthma Allergy. 2019;12:389–99.
20. Harris RF, et al. Psychosocial dysfunction in children and adolescents with eosinophilic esophagitis. J Pediatr Gastroenterol Nutr. 2013;57:500–5.
21. Lucendo AJ, et al. British Society of Gastroenterology (BSG) and British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) joint consensus guidelines on the diagnosis and management of eosinophilic oesophagitis in children and adults. Gut. 2022;71(8):1459-1487.
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