2025 AAAAI / WAO Joint Congress | American Academy of Allergy, Asthma & Immunology | iPharmaCenter
- ipharmaservices
- Mar 5
- 3 min read
Depemokimab Demonstrates Clinically Significant Benefits for Chronic Rhinosinusitis
Patients with Nasal Polyps (CRSwNP)Phase III ANCHOR-1 and ANCHOR-2 trials reveal notable improvements in nasal polyp size and obstruction with twice-yearly depemokimab compared to placebo.Positive effects were observed early and maintained throughout the 52-week study period.
GSK has unveiled comprehensive findings from the successful ANCHOR-1 and ANCHOR-2 phase III clinical trials, which evaluated the effectiveness and safety of depemokimab against placebo (both alongside standard care) in adults suffering from CRSwNP. Depemokimab is an experimental, ultra-long-acting monoclonal antibody designed to target interleukin-5 (IL-5), a critical protein involved in type 2 inflammation, which affects up to 85% of individuals with CRSwNP.
Both ANCHOR-1 (involving 271 participants) and ANCHOR-2 (involving 257 participants) achieved their primary objectives. Twice-yearly administration of depemokimab resulted in clinically meaningful and statistically significant enhancements in nasal polyp size and nasal obstruction—key indicators of disease severity—compared to placebo. A combined analysis of the two trials also highlighted improvements from baseline in the following areas:
Nasal polyp score (NPS, 0-8) at 52 weeks (treatment difference: -0.7).
Average nasal obstruction scores over weeks 49-52 (treatment difference: -0.24).
The trials enrolled a diverse patient population with varying symptom severity, mirroring real-world clinical scenarios. Benefits were evident at the first evaluation and persisted until the end of the 52-week study.
Secondary endpoint analyses from both studies revealed nominally significant improvements favoring depemokimab over placebo. These included reductions in rhinorrhea VRS scores, improvements in smell loss VRS scores, and enhancements in Lund-Mackay CT scores (a sinus imaging assessment) and SNOT-22 scores (a measure of disease-related quality of life).
By week 52 in the combined ANCHOR trials, 74% (200 patients) in the depemokimab group and 64% (164 patients) in the placebo group avoided interventions such as systemic corticosteroids (SCS), surgery, or disease-modifying medications. When focusing solely on surgery or disease-modifying medications, 88% (239 patients) in the depemokimab group and 83% (213 patients) in the placebo group did not require these interventions.
Adverse event rates were comparable between the depemokimab and placebo groups in both ANCHOR-1 (74% vs. 79%) and ANCHOR-2 (76% vs. 80%). These findings align with results from the SWIFT-1 and SWIFT-2 phase III trials, which evaluated depemokimab in asthma patients with type 2 inflammation. Fewer than 1% of depemokimab recipients and 1% of placebo recipients discontinued treatment or withdrew from the studies due to adverse events. No serious adverse events were attributed to the study treatment by investigators.
CRSwNP is a chronic condition affecting up to 4% of the general population. Current standard treatments, including surgery and SCS, are insufficient for managing the long-term effects of CRSwNP, leaving nearly half of patients with poorly controlled symptoms. While SCS provides short-term relief, repeated use can lead to severe side effects such as diabetes, cardiovascular disease, cataracts, and osteoporosis. Surgery, though beneficial, often results in polyp recurrence and symptom return within 18 months for up to 40% of patients due to unresolved underlying inflammation.
Data from ANCHOR-1, ANCHOR-2, SWIFT-1, and SWIFT-2 are being utilized to support regulatory submissions for depemokimab in treating asthma with type 2 inflammation and CRSwNP worldwide. Depemokimab is not yet approved for these conditions in any country.
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About ANCHOR-1 and ANCHOR-2
ANCHOR-1 and ANCHOR-2 were global, 52-week, randomized, double-blind, placebo-controlled, multicenter trials evaluating depemokimab's safety and efficacy in CRSwNP patients. ANCHOR-1 included 143 patients in the depemokimab plus standard care group and 128 in the placebo plus standard care group. ANCHOR-2 involved 129 patients in the depemokimab plus standard care group and 128 in the placebo plus standard care group.
All 528 participants had inadequately controlled CRSwNP, with bilateral nasal polyps (endoscopic NPS ≥5), and had either undergone prior CRSwNP surgery, received SCS treatment, or were intolerant to SCS. Patients received depemokimab or placebo every six months alongside standard care (maintenance intranasal corticosteroids).
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