Trial results for the ANCHOR-2 study (NCT05281523) investigating depemokimab for participants with chronic rhinosinusitis with nasal polyps (CRSwNP) were posted on ClinicalTrials.gov on 2025-09-09. The study demonstrated that depemokimab significantly reduced the Total Endoscopic Nasal Polyps (NP) Score by -0.6 (95% CI: -1.0 to -0.2) compared to placebo at Week 52, with a p-value of 0.004.
Background
The ANCHOR-2 study (NCT05281523) evaluated the efficacy and safety of depemokimab in participants diagnosed with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
Trial design
The ANCHOR-2 study (NCT05281523) was a Phase 3, randomized, placebo-controlled trial that enrolled 264 participants. The study investigated depemokimab in individuals with Nasal Polyps. Participants were assigned to receive either depemokimab or placebo. The study aimed to evaluate the efficacy and safety of depemokimab in this population.
Key results
The trial results demonstrated significant improvements across several endpoints for depemokimab compared to placebo at Week 52 in participants with CRSwNP.
- For the "Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read)":
- The depemokimab group showed a least squares mean change of -0.5 (Standard Error: 0.14).
- The placebo group showed a least squares mean change of 0.1 (Standard Error: 0.15).
- The difference in least squares means was -0.6 (95.0% CI: -1.0 to -0.2) with a p-value of 0.004.
- For the "Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52":
- The depemokimab group showed a least squares mean change of -0.77 (Standard Error: 0.076).
- The placebo group showed a least squares mean change of -0.53 (Standard Error: 0.078).
- The difference in least squares means was -0.25 (95.0% CI: -0.46 to -0.03) with a p-value of 0.025.
- For the "Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52":
- The depemokimab group showed a least squares mean change of -0.72 (Standard Error: 0.080).
- The placebo group showed a least squares mean change of -0.54 (Standard Error: 0.082).
- The difference in least squares means was -0.18 (95.0% CI: -0.4 to 0.05) with a p-value of 0.125.
- For the "Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52":
- The depemokimab group showed a least squares mean change of -0.56 (Standard Error: 0.066).
- The placebo group showed a least squares mean change of -0.30 (Standard Error: 0.068).
- The difference in least squares means was -0.26 (95.0% CI: -0.45 to -0.07) with a p-value of 0.007.
- For the "Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52":
- The depemokimab group showed a least squares mean change of -3.5 (Standard Error: 0.42).
- The placebo group showed a least squares mean change of -0.3 (Standard Error: 0.44).
- The difference in least squares means was -3.2 (95.0% CI: -4.4 to -2.0) with a p-value of 0.001.
- For the "Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52":
- The depemokimab group showed a least squares mean change of -15.9 (Standard Error: 2.83).
- The placebo group showed a least squares mean change of -6.0 (Standard Error: 2.87).
- The difference in least squares means was -9.9 (95.0% CI: -17.9 to -2.0) with a p-value of 0.015.
What this means
The results from the ANCHOR-2 trial indicate that depemokimab significantly improved several key clinical and patient-reported outcomes in individuals with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo. The statistically significant reductions in nasal polyp score, nasal obstruction, loss of smell, Lund Mackay CT score, and SNOT-22 total score suggest that depemokimab could offer a meaningful therapeutic option for managing this condition. While improvement in rhinorrhea was observed, it did not reach statistical significance in this analysis.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05281523, titled "Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)," were posted on 2025-09-09 on clinicaltrials.gov.