Depemokimab Demonstrates Significant Improvements in Rhinosinusitis with Nasal Polyps
GSK announced its ANCHOR-1 and ANCHOR-2 phase 3 trial results for depemokimab’s efficacy and safety in treating patients with chronic rhinosinusitis with nasal polyps.
Depemokimab demonstrated statistically significant results in treating patients who have chronic rhinosinusitis with nasal polyps (CRSwNP), according to a release from GSK.1
“Today’s data build on the body of evidence supporting depemokimab as an ultra-long-acting treatment and demonstrate significant reductions in nasal polyps with a twice-yearly dosing regimen,” said Kaivan Khavandi, MD, MRes, PhD, MBA, MRCP, SVP and Global Head of Respiratory, Immunology/Inflammation R&D at GSK. “With nearly 40% of patients needing repeat surgeries and many requiring long-term systemic corticosteroids, there is a clear medical need for alternative treatment options to provide sustained symptom improvement and help alleviate the debilitating burden of this disease.”
GSK announced the results from its ANCHOR-1 and ANCHOR-2 phase 3 clinical trials. Depemokimab is an investigational, “ultra-long-acting” monoclonal antibody manufactured to target interleukin-5 (IL-5), the main cytokine triggering inflammation in 85% of patients with CRSwNP.1
GSK announced ANCHOR-1 and ANCHOR-2 phase 3 clinical trial data at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, California. | image credit: Prostock-studio / stock.adobe.com
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“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, 2 key clinical measures of disease severity, versus placebo,” GSK said in the release.1
Each trial’s results were presented at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress that occurred in San Diego, California.3
“The proportion of adults in the USA who would meet the symptom criteria of chronic rhinosinusitis (CRS) is estimated to be 2.1% and, based on population studies, it is estimated to be between 2.1% and 4.3% in Europe,” wrote authors of a study published in the Journal of Asthma and Allergy.4 “Among all patients with CRS, approximately 20%-30% have CRSwNP.”
As the release stated, the ANCHOR-1 and ANCHOR-2 trials showed significant reductions in nasal polyp size and nasal obstruction for patients with CRSwNP. From baseline compared with placebo, patients saw significant reductions in both clinical measures at first assessment and sustained these improvements for 52 weeks.1
“In pooled analyses of the secondary endpoints from both studies, nominally significant improvements in favor of depemokimab versus placebo were observed,” GSK said in the release. “These include changes from baseline in rhinorrhoea VRS score, loss of smell VRS score, in addition to the Lund-Mackay CT score, a sinus imaging assessment, and SNOT-22, a disease-related quality of life measure.”
The phase 3 trials also measured the safety of depemokimab. Adverse events (AEs) occurred in at least 74% of all participant groups for depemokimab and placebo in both ANCHOR trials: 74% of the ANCHOR-1 depemokimab group, 79% of the ANCHOR-1 placebo group, 76% in the ANCHOR-2 depemokimab group, and 80% in the ANCHOR-2 placebo group.1
While failing to meet statistically significant results for the safety profiles of depemokimab, the drug could still help of millions of patients who have been unable to find relief from surgery and systemic corticosteroids (SCS).
“The current [standard of care], including surgery and SCS use, is suboptimal to address the long-term impact of CRSwNP, and almost half of patients live with poorly controlled symptoms,” GSK said in the release.1 “Although short-term SCS temporarily improves symptoms, repeated use is known to cause serious AEs such as increased risk of diabetes, cardiovascular disease, cataracts, and osteoporosis. Surgery also improves symptoms, but up to 40% of patients experience recurrence of nasal polyps and symptoms within 18 months due to the underlying inflammation not fully suppressed by surgery.”
With announcement of depemokimab’s efficacy, it has potential to become the most effective and safest treatment option for patients with CRSwNP. As the ANCHOR trials conclude, GSK will continue working to bring its developing medication to market.
“We're very encouraged by the results from the ANCHOR studies, which demonstrate the potential for depemokimab to offer targeted and sustained suppression of a key inflammatory pathway underlying nasal polyp growth and nasal obstruction,” concluded Khavandi in a previous press release regarding ANCHOR trial phase 3 results.5
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