Depemokimab, an ultra–long-acting anti–IL-5 biologic, demonstrated significant efficacy in reducing nasal polyp scores and obstruction symptoms in patients with chronic rhinosinusitis with nasal polyps, according to findings from the ANCHOR-1 and ANCHOR-2 phase III trials.
Data from the trials, which were conducted across 16 countries and included 528 participants, showed that patients with chronic rhinosinusitis with nasal polyps (CRSwNP) receiving depemokimab (100 mg subcutaneously every 26 weeks) had a significant reduction in total endoscopic nasal polyps score at 52 weeks compared to those receiving placebo; the integrated analysis reported a treatment difference of –0.7 (95% confidence interval [CI] = –0.9 to –0.4; P < .001). Additionally, mean nasal obstruction verbal response scale scores over weeks 4 to 52 improved significantly with depemokimab.
The trials also assessed secondary endpoints, including rhinorrhea, loss of smell, and the Sino-Nasal Outcome Test 22 (SNOT-22) scores. Depemokimab resulted in a nominally significant reduction in SNOT-22 scores (–8.1, 95% CI = –13.9 to –2.3; P = .007) compared to placebo. Lund-Mackay computed tomography scores also improved (–2.5, 95% CI = –3.4 to –1.7; P <.001).
Regarding clinical outcomes, fewer patients receiving depemokimab required systemic corticosteroids for CRSwNP (26% vs 36%; odds ratio = 0.58, 95% CI = 0.40–0.86; P = .006). The proportion of patients requiring CRSwNP surgery or entering a waiting list was also lower (16% vs 22%) among those taking depemokimab, though the risk reduction was not statistically significant (hazard ratio = 0.735, 95% CI = 0.495–1.092; P = .128).
"In addition to improving outcomes, depemokimab offers a reduced dosing schedule (twice per year) compared with currently approved biological drugs for CRSwNP, which all require dosing once every 2 [to] 4 weeks," wrote first study author Philippe Gevaert, MD, of Ghent University, and colleagues.
The researchers continuted, "Twice per-year dosing, informed by patient-physician discussions, might be more well-suited to supervised administration in clinic compared with more frequent dosing, mitigating concerns regarding adherence."
Safety outcomes were comparable between treatment groups, with adverse events occurring in 74% of patients in the depemokimab group and 79% of the placebo group in ANCHOR-1, and 76% vs 80% in ANCHOR-2.
Findings from the analysis indicate, according to investigators, that depemokimab may offer an alternative for patients with inadequately controlled CRSwNP, potentially reducing treatment burden compared to existing biologics requiring more frequent administration.
The study was funded by GSK. The authors reported no conflicts of interest.
