Evan Dellon, MD, MPH: “Promising” Phase 3 Cendakimab Data for Eosinophilic Esophagitis

Findings from a phase 3 study of cendakimab for eosinophilic esophagitis (EoE) in adult and adolescent patients highlight its durable safety and efficacy after 48 weeks of treatment.

The data were presented in a late-breaking abstract at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting in Philadelphia, Pennsylvania, by Evan Dellon, MD, MPH, director of the Center for Esophageal Diseases and Swallowing at the University of North Carolina Chapel Hill, and showed statistically significant improvements in symptoms and esophageal eosinophils with cendakimab through 24 weeks that were durable through 48 weeks versus placebo.

“The burden of EoE has really increased pretty rapidly over the last several decades,” Dellon explained to HCPLive, citing other research presented at ACG about its prevalence. “Initially, we thought EoE was a rare disease, and now what we're seeing is that it's becoming fairly common. The most recent epidemiologic data from the ACG meeting actually showed that it was about 1 in 700 now, which is about a quadrupling over the last 10 years since the last time we had information about it.”

With a clear need for effective therapies to reduce the health burden of EoE as it continues to affect more and more patients, new phase 3 data suggest cendakimab may be a promising new option. A recombinant, humanized, high-affinity, neutralizing monoclonal antibody targeting interleukin (IL)-13, cendakimab inhibits binding to its receptors IL-13Rα1/Rα2.

The study enrolled 430 patients 12–75 years of age with EoE, >4 dysphagia days over the 14-day period prior to day 1 evaluated using the modified Daily Symptom Diary, and lack of complete response to >8 weeks of proton pump inhibitor treatment. They were randomly assigned in a 1:1:1 ratio to cendakimab 360 mg once weekly for 48 weeks, cendakimab 360 mg once weekly for 24 weeks followed by cendakimab 360 mg every other week for 24 weeks, or placebo once weekly for 48 weeks.

In pts in the cendakimab once weekly group, there were significant improvements in coprimary endpoints of change in dysphagia days from baseline to week 24 and eosinophil histologic response (<6/hpf) at week 24 versus placebo. At week 48, efficacy in secondary endpoints was demonstrated with both cendakimab doses versus placebo.

“When you balance the good efficacy across all of these outcomes and the safety, I think it's very promising results for a phase 3 trial. This is great to have positive phase 3 data from another study in EoE,” Dellon said. “I think for providers and patients, it's an exciting time because we're seeing the development of a lot of therapeutics. We're seeing things come into practice and be approved, and ultimately seeing the impact on patients' health.”

Reference

^{Dellon ES, Charriez CM, Zhang S, et al. 43 - Cendakimab Efficacy and Safety in Adult and Adolescent Patients With Eosinophilic Esophagitis 48-Week Results From the Randomized, Placebo-Controlled, Phase 3 Study (Late-Breaking Abstract). Paper presented at: ACG 2024 Annual Scientific Meeting. Philadelphia, Pennsylvania. October 25-30, 2024.}