- 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
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.”
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.