GlaxoSmithKline (GSK) has unveiled promising outcomes from the Phase 3 ANCHOR-1 and ANCHOR-2 trials of depemokimab in adults affected by chronic rhinosinusitis with nasal polyps (CRSwNP).
Depemokimab is an experimental monoclonal antibody designed to target interleukin-5 (IL-5), a significant cytokine involved in type 2 inflammation, which is prevalent in a considerable proportion of CRSwNP cases.
The ANCHOR trials included 271 participants in the first study and 257 in the second. Both studies successfully reached their co-primary endpoints.
GSK SVP and respiratory, immunology/inflammation research and development global head Kaivan Khavandi said: “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.
“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.”
Administered twice yearly, depemokimab demonstrated notable improvements in the size of nasal polyps and nasal obstruction compared to placebo.
A pooled analysis of these trials revealed substantial reductions in nasal polyp scores at the 52-week mark, with a treatment difference of -0.7, and mean scores for nasal obstruction over weeks 49 to 52 showed a difference of -0.24.
The trials recruited participants with varying degrees of symptom severity, reflecting real-world clinical settings. The advantages of depemokimab were noticeable from the initial assessment and continued through week 52.
Evaluations of secondary endpoints also showed positive outcomes for depemokimab over placebo. These encompassed changes from baseline in rhinorrhoea scores, loss of smell scores, the Lund-Mackay CT score, which is a sinus imaging evaluation, and SNOT-22, which measures disease-related quality of life.
By week 52, 74% of individuals receiving depemokimab did not require intervention with systemic corticosteroids (SCS), surgery, or other medications that modulate disease, compared to 64% in the placebo group.
Additionally, when considering only surgical or disease-modulating medication interventions, 88% of those treated with depemokimab avoided these measures versus 83% on placebo.
According to GSK, depemokimab represents the first ultra-long-acting biologic evaluated in Phase 3 trials for CRSwNP. Its extended half-life and high-binding affinity enable a six-month dosing interval as demonstrated by the ANCHOR studies.
Adverse events were similarly distributed between both treatment groups across the ANCHOR trials.
In ANCHOR-1, adverse events occurred in 74% of the depemokimab group versus 79% with placebo; likewise, in ANCHOR-2, these figures were 76% versus 80%, respectively. These findings are consistent with earlier SWIFT-1 and SWIFT-2 trials involving asthma patients with type 2 inflammation.
Less than 1% of those on depemokimab discontinued due to adverse events, paralleling results for the placebo group.
Data from both ANCHOR and SWIFT studies will support regulatory submissions for depemokimab’s use in asthma with type 2 inflammation and CRSwNP across various international markets. Currently, depemokimab is yet to be approved for either indication worldwide.
