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An international research collaboration, sponsored by GSK, has found that depemokimab, an ultra-long-acting anti-IL-5 biologic, significantly improves symptoms in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The findings come from two Phase III clinical trials—ANCHOR-1 and ANCHOR-2—designed to evaluate the drug’s efficacy and safety.
Promising Results for a Difficult Condition
CRSwNP is characterized by persistent inflammation of the nasal and paranasal mucosa, leading to severe nasal obstruction, sinus pressure, loss of smell, and recurrent infections. Current treatment options include intranasal corticosteroids, systemic corticosteroids for symptom flare-ups, and surgical removal of nasal polyps. However, frequent medication use and the risk of recurrence make management challenging.
Biologics targeting type 2 inflammation, such as mepolizumab, dupilumab, and omalizumab, have improved outcomes for many patients. However, these treatments require frequent dosing every two to four weeks. Depemokimab, engineered for extended IL-5 inhibition, offers a potential alternative with a twice-yearly administration schedule.
Clinical Trial Findings
The ANCHOR-1 and ANCHOR-2 trials, published in The Lancet, were randomized, double-blind, placebo-controlled studies assessing the efficacy and safety of depemokimab. A total of 540 patients were enrolled, with 528 included in the final analysis across 190 clinical sites in 16 countries.
Patients received either 100 mg of depemokimab subcutaneously every 26 weeks or a placebo, in addition to standard-of-care treatment. The results showed:
- A significant reduction in nasal polyps score, with a treatment difference of -0.7 (95% CI -0.9 to -0.4) at week 52.
- Improvement in nasal obstruction severity, with a treatment difference of -0.24 (95% CI -0.39 to -0.08).
- Trends favoring depemokimab across secondary endpoints, including improvements in rhinorrhea severity, Lund-Mackay CT scores, and SNOT-22 scores.
- A 27% reduction in surgery risk, though this result did not reach statistical significance.
Safety and Future Implications
Depemokimab was well tolerated, with similar adverse event rates compared to the placebo group. Fewer than 1% of patients discontinued treatment due to side effects, and no deaths were reported.
The findings support depemokimab as a viable long-term treatment option for severe, uncontrolled CRSwNP. Its twice-yearly dosing schedule could improve adherence and quality of life for patients who currently require more frequent biologic treatments.
Conclusion
Depemokimab represents a significant advancement in the treatment of chronic rhinosinusitis with nasal polyps. While further studies and real-world data will be necessary to confirm long-term benefits, the results from ANCHOR-1 and ANCHOR-2 suggest that this ultra-long-acting biologic could offer a less burdensome alternative for patients with severe disease.
Disclaimer: This article summarizes clinical research findings and should not be interpreted as medical advice. Patients should consult their healthcare providers before considering any new treatment options.
