Amgen/AstraZeneca: TEZSPIRE positive Phase 3 CROSSING results in eosinophilic esophagitis
- TEZSPIRE met both co‑primary endpoints—histologic remission and dysphagia improvement (DSQ)—at week 24, with effects maintained through week 52.
- CROSSING randomized 368 patients (1:1:1) to low or high TEZSPIRE dose or placebo; dosing was subcutaneous every four weeks.
- Histologic remission was defined as peak esophageal eosinophil count ≤6 per high‑power field; dysphagia was assessed by the Dysphagia Symptom Questionnaire (DSQ).
- Safety profile reported as generally consistent with approved indications; hypersensitivity (including postmarketing anaphylaxis) and vaccine/helminth cautions noted.
Top-line efficacy
TEZSPIRE (tezepelumab‑ekko) produced statistically significant and clinically meaningful improvements across the trial's co‑primary and key secondary endpoints at week 24, with those improvements sustained through week 52. The co‑primary endpoints were histologic remission and the frequency and severity of dysphagia as measured by the DSQ.
Trial design and endpoints
CROSSING was a randomized, double‑blind, placebo‑controlled Phase 3 study in adolescents and adults (aged 12–80) with symptomatic, histologically active and uncontrolled eosinophilic esophagitis on stable background therapy. A total of 368 patients were randomized 1:1:1 to receive a low or high dose of TEZSPIRE or placebo, administered subcutaneously every four weeks. Histologic remission was defined as peak esophageal eosinophil count ≤6 per high‑power field; the DSQ captured dysphagia over 14‑day periods with scores from 0 to 84 (higher = worse).
Safety and mechanism
The safety profile in CROSSING was described as generally consistent with TEZSPIRE's approved indications. Warnings in the prescribing information include hypersensitivity reactions (postmarketing anaphylaxis reported), potential effects on response to helminth infection, and avoidance of live attenuated vaccines. TEZSPIRE is a human monoclonal antibody that blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine implicated across epithelial‑driven inflammatory diseases.
Next steps and collaboration
Full results will be submitted to regulatory authorities and presented to the scientific community at an upcoming medical meeting. Amgen and AstraZeneca co‑develop and will share global costs, profits and losses for TEZSPIRE; AstraZeneca leads global development while Amgen manufactures and supplies the product.
Source: Amgen
