Cendakimab sustains ‘promising results’ for safety, efficacy in EoE at 48 weeks
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Key takeaways:
- Cendakimab sustained improvements in symptoms and reductions in esophageal eosinophils for patients with EoE at week 48.
- Cendakimab was generally safe and well-tolerated through 48 weeks.
PHILADELPHIA — A once-weekly 360 mg dose of cendakimab sustained improvements in symptoms and endoscopic/histologic features of eosinophilic esophagitis at 48 weeks, according to data presented at the ACG Annual Scientific Meeting.
In a previous phase 2 study, cendakimab, a monoclonal, high-affinity, selective antibody inhibiting binding to both interleukin-13 receptor alpha-1 and IL-13 receptor alpha-2, had been shown to reduce mean esophageal eosinophil counts and improve symptoms and endoscopic features of EoE after 24 weeks of treatment.
At the ACG meeting, Evan S. Dellon, MD, MPH, FACG, director of the Center for Esophageal Diseases and Swallowing at UNC School of Medicine, reported on positive phase 3 data “that follows-up promising results of the phase 2 study for this anti-IL-13 biologic treatment” at 48 weeks.
In this multicenter, randomized, double-blind, placebo-controlled study, Dellon and colleagues enrolled patients aged 12 to 75 years with EoE (n = 430) who had exhibited more than 4 days of dysphagia in the previous 2 weeks and demonstrated inadequate response to proton pump inhibitors after 8 weeks.
The researchers randomly assigned patients to once-weekly cendakimab 360 mg for 48 weeks, once-weekly cendakimab 360 mg for 24 weeks followed by the same dose every other week for 24 weeks, or placebo for 48 weeks.
“From week 24 to 48, patients originally randomized to placebo were maintained on placebo unless they had a significant EoE flare, at which point they could change to an open-label segment of the study,” Dellon told Healio. “Patients originally randomized to cendakimab 360 mg weekly were either maintained on that dose from week 24 to 48 or changed to every other week dosing in blinded fashion, so the entire 48-week period remained blinded.”
Coprimary endpoints for the study included mean change in dysphagia days from baseline to week 24 and proportion of patients exhibiting eosinophil histologic response at week 24. The study’s secondary endpoints were focused on changes from baseline to 48 weeks, including dysphagia days, proportion of patients with histologic response, EoE Endoscopic Reference Score, EoE histology scoring system score grade or stage, modified daily symptom diary composite score and safety.
According to study results, compared with placebo, both groups receiving 48-week cendakimab 360 mg weekly doses and 24-week cendakimab 360 mg weekly followed by dosing every other week for 24 weeks demonstrated durable improvements in symptoms and endoscopic/histologic features of EoE, consistent with results observed at 24 weeks.
“In general, the responses at 24 weeks were maintained to 48 weeks,” Dellon noted.
Patients who received cendakimab 360 mg weekly doses for 48 weeks exhibited significant improvement in change in dysphagia days from baseline as well as eosinophil histologic response at week 24 compared with the placebo group.
At 48 weeks, drug-related adverse events were reported in 34.1% of patients who received cendakimab 360 mg weekly doses for 48 weeks, 32.5% of patients treated with cendakimab 360 mg weekly for 24 weeks followed by every-other-week dosing for 24 weeks, and 21% of patients who received placebo.
“Given that this is a phase 3 trial that showed cendakimab was both effective and well-tolerated, the data support potential use in clinical practice if the medication is ultimately approved,” Dellon told Healio. “We await subgroup analyses of the phase 3 data [and] longer-term outcome data are needed. In addition, because approximately 70% of patients in the study were either refractory or intolerant to topical steroids, the effect of cendakimab in a more treatment-naïve population is of interest.”
He added: “Cendakimab is another effective biologic for treatment of EoE, and while the exact placement of this medication in the EoE treatment algorithm is not yet known, gastroenterologists should be aware that this treatment may come into clinical practice if it is ultimately approved.”
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Dellon ES, et al. 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). Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
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