Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Summary

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Timeline

Start

2022-04-22

Primary completion

2024-07-30

Completion

2024-08-27

Outcome

Met primary endpoint

registry analysis (other test); Depemokimab vs Placebo; p <0.001; Difference in Least Square Means -0.7 (95% CI -1.1 to -0.3); Mixed Models Analysis NCT05274750 ↗

registry analysis (other test); Depemokimab vs Placebo; p = 0.047; Difference in Least Square Means -0.23 (95% CI -0.46 to 0.00); Mixed Models Analysis NCT05274750 ↗

paper Depemokimab had statistically significant improvements from baseline versus placebo in the coprimary endpoints of total nasal polyps score PMID 40037388 ↗

release “ANCHOR-1 (N=271) and ANCHOR-2 (N=257) met their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction, two key clinical measures of disease severity, versus placebo.” gsk.com ↗

Publications

• Background Gevaert P, Cornet M, Mullol J, De Corso E, Keles Turel N, Desrosiers M, et al. . ANCHOR-1/-2 primary data including pooled analysis ms. Lancet. PMID: 40037388 DOI: 10.1016/S0140-6736(25)00197-7
• Jackson DJ, Bourdin A, Blackorby A, Leslie A, Vichiendilokkul A, Howarth P, Karkoszka N, Fujieda S, Cornet M. Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. Adv Ther. 2026 Feb;43(2):880-897. doi: 10.1007/s12325-025-03457-4. Epub 2025 Dec 29.
• Gevaert P, Desrosiers M, Cornet M, Mullol J, De Corso E, Keles Turel N, Maspero J, Fujieda S, Zhang L, Sousa AR, Woods SJ, Davis AM, Schalkwijk S, Edwards D, Ranganathan P, Follows R, Marshall C, Han JK; ANCHOR-1 and ANCHOR-2 trial investigators. 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. Lancet. 2025 Mar 15;405(10482):911-926. doi: 10.1016/S0140-6736(25)00197-7. Epub 2025 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Depemokimab	Protein / enzyme biologic	100 mg	Subcutaneous

Indications