Tezspire Demonstrates Positive Phase 3 Results in Eosinophilic Esophagitis Across Both Co-Primary and All Key Secondary Endpoints

Amgen and AstraZeneca announced positive top-line results from the Phase 3 CROSSING trial of TEZSPIRE in patients living with eosinophilic esophagitis (EoE). TEZSPIRE demonstrated statistically significant and clinically meaningful advancement in the co-primary and significant secondary endpoints at week 24, which were sustained through week 52. The co-primary endpoints were histologic remission and the frequency and severity of dysphagia. The safety profile of TEZSPIRE was generally consistent with its permitted indications.

EoE is a long-term and progressive epithelial-driven inflammatory disease of the esophagus affecting more than 470,000 patients in the U.S., with the occurrence growing five-fold since 2009. Esophageal inflammation can cause dysphagia, food impaction, and esophageal rupture. For patients, the challenges of food shifting slowly or becoming stuck make daily meals difficult and stressful. Nearly half of patients, involving adolescents, do not sustain adequate disease control with current first-line management, which involves dietary restriction, swallowed topical corticosteroids, and proton pump inhibitors.

"We're pleased that TEZSPIRE showed efficacy in a third epithelial-driven inflammatory condition, eosinophilic esophagitis," said Jay Bradner, M.D., executive vice president of Research and Development, Artificial Intelligence and Data at Amgen. "In this Phase 3 trial, TEZSPIRE improved both the underlying inflammation and the swallowing difficulties that can make eosinophilic esophagitis so disruptive for patients. That combination is important for patients and builds confidence in TEZSPIRE as a potential new treatment for people struggling with EoE."

CROSSING is a randomized, double-blind trial that assessed the efficiency and safety of TEZSPIRE at one of two doses administered subcutaneously every four weeks as compared to placebo in adults and adolescents with symptomatic and uncontrolled EoE while on maintenance treatment. In the trial, the first co-primary endpoint, histologic remission, was defined as having a low count of peak eosinophils in the esophageal tissue. The second co-primary endpoint, the incidence and severity of dysphagia, was assessed using the patient-reported Dysphagia Symptom Questionnaire (DSQ) and measured as a mean transformation from baseline in DSQ score.

"Despite the availability of first-line therapies or dietary interventions, many patients with eosinophilic esophagitis still experience substantial burden, including difficulty swallowing food and emotional and daily-life impacts of the disease," said Arjan Bredenoord, M.D., gastroenterologist and professor at the Amsterdam University Medical Center, Amsterdam, the Netherlands, and primary investigator in the trial. "The impressive results from the CROSSING trial sustained over 52 weeks demonstrate that tezepelumab, taken every four weeks, could provide a new approach to treating EoE, with the potential to help more patients achieve remission and symptom improvement."

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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 serious asthma. TEZSPIRE is not directed 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 Important Safety Information

CONTRAINDICATIONS

Known hypersensitivity to Tezepelumab Ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions

Hypersensitivity reactions were observed in the clinical trials following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions occur within hours of administration, but in some instances have a delayed onset that is in days. In the adverse reaction of a hypersensitivity reaction, consider the advantages and challenges for the individual patient to identify whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease

TEZSPIRE should not be used to treat acute asthma signs, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage

Do not discontinue systemic or inhaled corticosteroids abruptly based on initiation of treatment with TEZSPIRE. Decreases in corticosteroid dose, if suitable, should be gradual and performed under the direct supervision of a doctor. lessening in corticosteroid dose may be related to systemic withdrawal symptoms and unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection

It is unidentified if TEZSPIRE will influence a patient's response to helminth infections. Manage patients with pre-existing helminth infections before getting therapy with TEZSPIRE. If patients become infected while getting TEZSPIRE and do not respond to anti-helminth management, discontinue TEZSPIRE until infection is resolved.

Live Attenuated Vaccines

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

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About TEZSPIRE (tezepelumab-ekko)

TEZSPIRE is a first-in-class human monoclonal antibody that works on a significant source of inflammation: the airway and gut epithelia, which are the first point of contact for various viruses, allergens, pollutants, and different environmental triggers and insults. Particularly, TEZSPIRE targets and blocks thymic stromal lymphopoietin (TSLP), a significant epithelial cytokine that sits at the top of major inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic, and other types of epithelial-driven inflammation related with serious asthma, long-lasting rhinosinusitis with nasal polyps (CRSwNP), chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE).

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