Amgen's tezepelumab hits Phase 3 targets in esophageal disorder trial

Amgen (NASDAQ: AMGN) and AstraZeneca announced full results from the Phase 3 CROSSING trial showing that tezepelumab (TEZSPIRE) met co-primary and key secondary endpoints in adolescent and adult patients with eosinophilic esophagitis (EoE), a chronic inflammatory disorder of the esophagus.

In the trial, 64.8% of patients receiving the 210 mg dose and 68.9% receiving the 420 mg dose achieved histologic remission at week 24, compared with 3.5% on placebo. Dysphagia symptom scores, measured by the Dysphagia Symptom Questionnaire, fell by 18.8 points (210 mg, p=0.049) and 22.0 points (420 mg, p<0.001) from baseline, versus 14.7 points for placebo.

Results were sustained through week 52. Histologic remission was achieved by 67.8% (210 mg) and 63.3% (420 mg) of patients, compared with 5.4% on placebo (both p<0.001). Symptom score reductions from baseline reached 22.1 points and 24.0 points respectively, versus 13.2 points for placebo (both p<0.001).

At week 52, 34.4% (210 mg) and 29.5% (420 mg) of patients achieved total endoscopic remission, defined as the absence of all visible features of EoE, compared with 4.1% on placebo (both p<0.001).

The trial enrolled 368 patients aged 12 to 80, randomized 1:1:1 to receive 210 mg tezepelumab, 420 mg tezepelumab, or placebo, administered subcutaneously every four weeks. Patients were permitted to continue stable background therapies including proton pump inhibitors and swallowed topical corticosteroids.

The most frequently reported adverse events in the TEZSPIRE groups were upper respiratory infection, headache and diarrhea. The safety profile was described as consistent with the drug's approved indications.

TEZSPIRE is currently approved in the U.S. for severe asthma and chronic rhinosinusitis with nasal polyps, but is not yet approved for EoE. The results were presented at United European Gastroenterology Week 2026 in Barcelona, Spain, according to a press release from Amgen.

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