Cendakimab meets primary endpoints in eosinophilic oesophagitis

Cendakimab outperformed placebo in patients with eosinophilic oesophagitis (EoE) across various efficacy endpoints in a phase 3 study.

Cendakimab shows superior efficacy in eosinophilic oesophagitis

A randomised-controlled, phase 3 trial (NCT04753697) tested the IL-13 inhibitor cendakimab against a placebo in a large population of patients with EoE (n=430) between 12 and 75 years of age1. Participants were allocated to a weekly dose of cendakimab 360 mg subcutaneously (n=286) or a placebo (n=144). The co-primary endpoints were the mean change from baseline to week 24 in dysphagia days, using the modified daily symptom diary, and the proportion of patients with a histologic response (peak eosinophil count ≤6/high power field) at week 24. Dr Alain Schoepfer (University of Lausanne, Switzerland) presented the key findings.

For the first primary endpoint, the least square mean changes were -6.1 days for the intervention arm and -4.2 days for the placebo arm (delta -1.9; 95% CI -3.0 to -0.8; P=0.0005). The other primary endpoint also significantly favoured the cendakimab arm over the placebo arm (28.6% vs 2.2%; delta 26.4%; 95% CI 20.6–32.2; P<0.0001). “Cendakimab was superior to placebo in terms of endoscopic response and other key secondary endpoints as well,” commented Dr Schoepfer. “Furthermore, the findings were consistent in steroid-refractory patients.”

Serious AEs were rare

The adverse event (AE) rates were fairly comparable between groups, with any AEs occurring in 76.4% of the participants on cendakimab and in 68.5% of the participants on placebo. Serious AEs were rare, with rates of 1.8% and 2.8% in the active arm and control arm, respectively. Injection site reactions (16.9%), COVID-19 (14.1%), and headache (9.2%) were the most common AEs in the cendakimab arm.

“In this large phase 3 study, cendakimab met the co-primary endpoints, demonstrating statistically significant improvements in symptoms and reductions in oesophageal eosinophils in patients with EoE through 24 weeks,” decided Dr Schoepfer.

Source
  1. Schoepfer A, et al. Cendakimab efficacy and safety in adult and adolescent patients with eosinophilic esophagitis: 24-week results from the randomized, placebo-controlled, phase 3 study. LB11, UEG Week 2024, 12–15 October, Vienna, Austria