Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials.
Summary
Two replicate phase 3 randomized, double-blind trials showed depemokimab significantly reduced total nasal polyp score and nasal obstruction at 52 weeks versus placebo with comparable safety. The ultra–long-acting anti–IL-5 enables twice-yearly dosing, potentially reducing treatment burden for CRSwNP.
Key Findings
- Met both co-primary endpoints: greater reductions in total endoscopic nasal polyp score and mean nasal obstruction score vs placebo at week 52.
- Consistent efficacy across two parallel, replicate phase 3 trials with integrated analyses showing similar effect sizes.
- Safety profile comparable to placebo with similar rates of adverse events across trials.
Clinical Implications
Depemokimab could become a convenient biologic option for severe, type 2–driven CRSwNP uncontrolled on standard therapy, with less frequent dosing than current agents.
Why It Matters
First replicated phase 3 evidence that a twice-yearly anti–IL-5 biologic improves CRSwNP outcomes with acceptable safety, offering a new dosing paradigm.
Limitations
- Effect sizes were modest in absolute terms on ordinal symptom scales
- Follow-up limited to 52 weeks; long-term durability and surgical avoidance not yet established
Future Directions
Head-to-head comparisons with existing biologics, long-term durability, health-economic analyses, and biomarker-driven patient selection.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Replicated phase 3 randomized, double-blind, placebo-controlled trials
- Study Design
- OTHER