Amgen and AstraZeneca: TEZSPIRE shows histologic, symptom and endoscopic remission in EoE (CROSSING)
- Histologic remission at week 24: 64.8% (210 mg) and 68.9% (420 mg) versus 3.5% placebo (p<0.001); sustained at week 52: 67.8% and 63.3% versus 5.4% (p<0.001).
- Dysphagia (DSQ) improvements at week 24: reductions of 18.8 points (210 mg; p=0.049) and 22.0 points (420 mg; p<0.001) versus 14.7 points for placebo; sustained at week 52 (22.1 and 24.0 vs 13.2; both p<0.001).
- Total endoscopic remission (no visible EoE features) at week 52: 34.4% (210 mg) and 29.5% (420 mg) versus 4.1% placebo (p<0.001).
- CROSSING randomized 368 patients (ages 12–80) 1:1:1 to TEZSPIRE 210 mg, 420 mg or placebo subcutaneously every four weeks; safety profile consistent with approved indications (most common AEs: nasopharyngitis, headache, diarrhea).
Key results
In the Phase 3 CROSSING trial, TEZSPIRE (tezepelumab-ekko) administered subcutaneously every four weeks at 210 mg and 420 mg produced statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 that were sustained through week 52. Histologic remission rates at week 24 were 64.8% (210 mg) and 68.9% (420 mg) versus 3.5% placebo (p<0.001), and at week 52 were 67.8% and 63.3% versus 5.4% placebo (p<0.001).
Symptom and endoscopic outcomes
TEZSPIRE reduced dysphagia as measured by the Dysphagia Symptom Questionnaire (DSQ): at week 24 mean DSQ reductions from baseline were 18.8 points (210 mg; p=0.049) and 22.0 points (420 mg; p<0.001) versus 14.7 points for placebo; at week 52 reductions were 22.1 and 24.0 points versus 13.2 for placebo (both p<0.001). Total endoscopic remission (no visible EoE features) at week 52 occurred in 34.4% (210 mg) and 29.5% (420 mg) of patients versus 4.1% placebo (p<0.001).
Trial design
CROSSING randomized 368 patients aged 12–80 in a 1:1:1 ratio to receive TEZSPIRE 210 mg, 420 mg or placebo subcutaneously every four weeks. Co-primary endpoints at week 24 were histologic remission (peak esophageal eosinophil count ≤6 per high-power field) and mean change in DSQ score.
Safety and next steps
TEZSPIRE's safety profile in CROSSING was consistent with its approved indications; the most frequent adverse events were nasopharyngitis, headache and diarrhea. Results will be presented in a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona.
Source: Amgen