GSK Reports Positive Phase III Results for Depemokimab in Chronic Rhinosinusitis with Nasal Polyps

LONDON, UK I October 14, 2024 I GSK plc (LSE/NYSE: GSK) today revealed promising headline results from their phase III clinical trials, ANCHOR-1 and ANCHOR-2. These trials evaluated the efficacy and safety of depemokimab in comparison to a placebo for adults suffering from Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). Both studies successfully met their co-primary endpoints, which included a change from baseline in the total endoscopic nasal polyp score at week 52 and a change from baseline in the mean nasal obstruction score from weeks 49 through 52. The incidence and severity of treatment-emergent adverse events were consistent across patients treated with depemokimab and those given a placebo. Ongoing analysis is being conducted on the data, and the comprehensive results will be shared at an upcoming scientific congress.

Kaivan Khavandi, SVP of Global Respiratory and Immunology R&D at GSK, expressed optimism about the results: “Millions worldwide suffer from uncontrolled CRSwNP, often characterized by type 2 inflammation markers. These patients frequently endure high levels of corticosteroid exposure and recurrence of nasal polyps post-surgery. The ANCHOR studies’ findings are promising, indicating that depemokimab may provide targeted and sustained suppression of a critical inflammatory pathway responsible for nasal polyp growth and nasal obstruction. These results, together with recent phase III data in severe asthma, will be utilized for regulatory submissions globally.”

Depemokimab is notable for being the first ultra-long-acting biologic tested in phase III trials, featuring an extended half-life and high affinity and potency for interleukin-5 (IL-5). This could potentially allow dosing once every six months for CRSwNP patients. IL-5 is prevalent in nasal polyp tissue and is pivotal in type 2 inflammation. These findings are part of GSK’s broader strategy to improve treatment options for those with type 2 inflammatory conditions such as CRSwNP. If inflammation that drives the disease can be kept in check over extended periods, it could significantly benefit patients by reducing the risk of recurrent inflammation due to missed doses. This approach might also decrease the frequency of clinical visits required.

CRSwNP is a chronic condition affecting up to 4% of the general population, with 40% of these cases being uncontrolled. It results from inflammation of the nasal lining, leading to the growth of nasal polyps. Symptoms include nasal obstruction, loss of smell, facial pressure, sleep disturbances, infections, and nasal discharge, which can adversely impact the emotional and physical well-being of affected individuals. Approximately 80% of CRSwNP patients exhibit type 2 airway inflammation, identifiable through blood eosinophil count, which correlates with more severe disease and symptoms. These patients often have a history of sinonasal surgery, which carries a high risk of nasal polyp recurrence and involves substantial use of oral corticosteroids, known for their severe complications.

The results from the ANCHOR-1 and ANCHOR-2 trials, along with data from the SWIFT-1 and SWIFT-2 trials assessing depemokimab in severe asthma, will support regulatory filings worldwide. Currently, depemokimab has not received approval from any regulatory body.

ANCHOR-1 and ANCHOR-2 were structured as 52-week, randomised, double-blind, parallel group, placebo-controlled, multi-centre trials. ANCHOR-1 included 143 subjects receiving depemokimab and 128 on placebo, while ANCHOR-2 included 129 depemokimab recipients and 128 on placebo.

Depemokimab’s development program leverages its extended half-life, high potency, and binding affinity for IL-5 to provide prolonged inhibition of inflammatory functions with bi-annual dosing. The phase III program also explores depemokimab’s potential in other IL-5 mediated diseases, such as severe asthma, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES). The initial phase III trials for severe asthma, SWIFT-1 and SWIFT-2, have been published in the New England Journal of Medicine.

GSK continues to innovate in respiratory medicine, aiming to enhance treatment outcomes and quality of life for individuals with various respiratory diseases, including asthma and COPD, as well as rarer conditions like systemic sclerosis with interstitial lung disease. Through cutting-edge science and technology, GSK seeks to address underlying disease dysfunctions and prevent disease progression.