depemokimab (GSK3511294) / GSK - LARVOL DELTA

Distribution of Baseline Type 2 Inflammation Characteristics in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Biologic Clinical Trials: A Comparative Assessment (EAACI 2025) - P3 | "Patients from the SINUS-24/52 (dupilumab, anti-interleukin [IL]-4Rα), POLYP-1/2 (omalizumab, anti-IgE), SYNAPSE (mepolizumab, anti-IL-5), and OSTRO (benralizumab, anti-IL-5Rα) trials were included, as well as patients from the replicate Phase III ANCHOR-1/2 trials. ANCHOR-1/2 investigated the efficacy and safety of depemokimab (ultra-long-acting anti-IL-5 administered twice yearly) versus placebo...These differences may have been driven by factors including distinct geographic footprints, or biologic availability during the later trials. Patients with CRSwNP and biomarkers of type 2 inflammation have greater disease burden and comprise a more biologic-treatment responsive population; the proportion of such patients at baseline should be considered when interpreting outcomes from clinical studies of biologics in CRSwNP."

Clinical • Immunology • Inflammation • IL5

Twice-Yearly Depemokimab Efficacy is Sustained Across Seasons in Patients with Asthma: Analyses of Pooled Phase III SWIFT-1/2 Studies (EAACI 2025) - P3 | "The annualised exacerbation rates (95% CI) in the depemokimab arm remained broadly consistent across all four seasons (spring: 0.46 [0.35, 0.61]; summer: 0.47 [0.36, 0.62]; autumn: 0.56 [0.44, 0.71]; winter: 0.57 [0.45, 0.72]; however, in the placebo arm exacerbation rates were, as expected, numerically lower in summer (spring: 1.10 [0.84, 1.43]; summer: 0.78 [0.58, 1.07]; autumn: 1.23 [0.97, 1.56]; winter: 1.30 [1.03, 1.63]) ( Figure ). Conclusion Overall, twice-yearly depemokimab demonstrated a sustained clinical benefit for patients with type 2 asthma across all four seasons, regardless of additional exacerbation triggers over the autumn and winter months."

Clinical • P3 data • Immunology • Inflammation • IL5

Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Comorbid Asthma Experience Early and Sustained Benefit with Depemokimab in the Randomised, Double-Blind, Parallel-Group, Replicate ANCHOR-1/2 Studies (EAACI 2025) - P3 | "For coprimary endpoints, effects were observed early (i.e. at first assessment) and sustained over 52 weeks. These findings support use of twice-yearly depemokimab as a treatment option for patients with CRSwNP and comorbid asthma."

Clinical • Immunology • Inflammation • IL5

Mechanisms and Treatment of Type 2 High and Low Asthma Endotypes. (PubMed, Clin Exp Allergy) - "Approved biologics for asthma management include using various interleukin antagonists and anti-immunoglobulin E, with Tezepelumab offering promising treatments for both type-2 high and type-2 low asthma patients. Novel therapeutic candidates, such as Itepekimab and depemokimab, have demonstrated promising results in a Phase 2 clinical trial in moderate-to-severe asthma patients."

Journal • Review • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Depemokimab reduces exacerbations in severe asthma versus other biologics: A multilevel network meta-regression (ERS 2025) - No abstract available

Asthma • Immunology • Respiratory Diseases

Twice-yearly depemokimab reduces exacerbations versus placebo in patients with asthma across age of onset/duration subgroups: Phase III SWIFT-1/2 studies (ERS 2025) - No abstract available

Clinical • P3 data • Asthma • Immunology • Respiratory Diseases

Twice-yearly depemokimab demonstrates efficacy in patients with asthma and comorbid chronic rhinosinusitis with nasal polyps (CRSwNP): Phase III SWIFT-1/2 studies (ERS 2025) - No abstract available

Clinical • P3 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Twice-yearly depemokimab is well-tolerated in randomised, double-blind, placebo-controlled Phase III SWIFT and ANCHOR studies (ERS 2025) - No abstract available

Clinical • P3 data • Allergic Rhinitis • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Twice-yearly depemokimab demonstrates efficacy in patients with asthma across baseline medium- and high-dose ICS subgroups: Phase III SWIFT-1/2 studies (ERS 2025) - No abstract available

Clinical • P3 data • Asthma • Immunology • Respiratory Diseases

Twice-yearly depemokimab demonstrates sustained pharmacokinetics and pharmacodynamics across Phase I and III trials (ERS 2025) - No abstract available

P1 data • PK/PD data • Allergic Rhinitis • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Depemokimab is associated with early and sustained improvements in patient-reported outcomes in CRSwNP: Data from the ANCHOR-1/2 trials (ERS 2025) - No abstract available

Clinical • Patient reported outcomes • Chronic Rhinosinusitis With Nasal Polyps

Clinical remission in patients with asthma treated with twice-yearly depemokimab in the Phase III SWIFT-1/2 studies (ERS 2025) - No abstract available

Clinical • P3 data • Asthma • Immunology • Respiratory Diseases

GSK’s depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (GSK Press Release) - "GSK has submitted a New Drug Submission (NDS) to Health Canada for depemokimab for two proposed indications: The first indication is as an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller. The second indication is as an add-on maintenance treatment of adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The NDS is based on data from the positive SWIFT and ANCHOR trials."

Canada filing • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Inflammation

Twice-yearly Depemokimab Reduces Exacerbations and Improves Quality of Life in Patients With Uncontrolled Asthma Symptoms at Baseline: Subgroup Analyses of the Phase III SWIFT-1/2 Studies (ATS 2025) - P3 | "Twice-yearly depemokimab consistently reduced exacerbations versus placebo regardless of baseline asthma control, suggesting uncontrolled asthma symptoms are not required to experience an exacerbation reduction in patients with a history of exacerbations. Depemokimab-treated patients who were symptomatic at baseline trended toward sustained clinical improvement in quality of life and better asthma control. Reference: 1."

Clinical • HEOR • P3 data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Sustained Efficacy of Depemokimab Over Time in Type 2 Asthma Characterized by Blood Eosinophils: Pooled Data From the Phase III SWIFT-1/2 Studies (ATS 2025) - P3 | "Twice-yearly depemokimab treatment was associated with numerically greater benefits compared with placebo, sustained over the depemokimab dosing interval, in overall health and risk of exacerbations in patients with type 2 asthma. The finding of this pooled analysis of the SWIFT-1/2 studies supports the sustained inhibition of type 2 inflammation by depemokimab. Reference: 1."

Clinical • P3 data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Psychometric Evaluation Supports Use of Symptom-Specific Verbal Response Scales in Patients With Chronic Rhinosinusitis With Nasal Polyps (ATS 2025) - P3 | " This analysis used interim pooled data from the Phase III, 52-week, randomized, double-blind ANCHOR-2 depemokimab study, which included adults with CRSwNP, an endoscopic NP score ≥5 (min of 2/nasal cavity), presence of ≥2 different symptoms for ≥12 weeks before the first visit, and prior systemic corticosteroid (SCS) use in the past 2 years, SCS intolerance, and/or prior sinus surgery... These findings suggest the symptom-specific VRS and composite mean scores demonstrate appropriate psychometric properties in patients with CRSwNP and propose thresholds for defining responders."

Clinical • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis

Twice-Yearly Depemokimab Demonstrates Efficacy in Patients With Asthma in China and Japan: Subpopulation Analyses of the SWIFT-1/2 Studies (ATS 2025) - P3 | "Twice-yearly depemokimab improves outcomes in patients with type 2 asthma in China, Japan, and Asia overall. Reference: 1. Jackson DJ et al."

Clinical • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Exploring Global Geographic Variation in Exacerbation Rates in Randomized Controlled Trials of Biologics in Patients With Severe Asthma: A Systematic Literature Review (ATS 2025) - P3 | "Subgroup and post hoc analyses by geographic region of RCTs for tezepelumab (NAVIGATOR), benralizumab (CALIMA/SIROCCO), reslizumab (NCT02452190), dupilumab (TRAVERSE open-label extension), and depemokimab (SWIFT-1/2) consistently reported the smallest treatment effects on exacerbation rates in Central East European countries (Table). Geographical variation in exacerbation rate was consistently observed across biologic RCTs in patients with severe asthma. Lower biologic treatment effects were observed in Central East Europe versus other regions due to lower exacerbation rates in the placebo arm. This could lead to misinterpretation of efficacy results if not considered in future studies."

Clinical • Review • Asthma • Immunology • Respiratory Diseases • IL5

Regional Variation in Response to Depemokimab Versus Placebo in Patients With Asthma With Type 2 Inflammation: Subgroup Analyses of the Phase III SWIFT-1/2 Studies (ATS 2025) - P3 | "Twice-yearlydepemokimab efficacy in the SWIFT-1/2 trials was broadly consistent across regions. However, differential exacerbation reduction was observed among patients in Central East Europe, where there was a substantial placebo response, versus other regions. This could reflect variation in clinical practice and adherence to background therapies prior to trial initiation."

Clinical • P3 data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Model-based Comparison of the Pharmacokinetic/Pharmacodynamic and Eosinophilic Response of Benralizumab Versus Depemokimab at 12 Weeks (ATS 2025) - "Using PK/PD model simulations, a single dose of benralizumab 30 mg Q6M is predicted to result in higher eosinophil depletion at 12 weeks than a single dose of depemokimab 100 mg Q6M. The higher eosinophil depletion with benralizumab is predicted to have higher variability than depemokimab. These analysis results are dependent on the quality of the supplied models and the depemokimab PK/PD model developed; other models might produce different results."

PK/PD data • Asthma • Immunology • Respiratory Diseases • IL5

OCEAN: Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With Relapsing or Refractory Eosinophilic Granulomatosis With Polyangiitis (EGPA) (clinicaltrials.gov) - P3 | N=160 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: May 2026 ➔ Oct 2026

Head-to-Head • Trial completion date • Trial primary completion date • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis • MPO

Reappraisal of biologic efficacy from phase 3 trials in refractory chronic rhinosinusitis and nasal polyps. (PubMed, J Allergy Clin Immunol Pract) - "Anti-TSLP (tezepelumab) or anti-IL4Rα (dupilumab) provide the best improvements in co-primary end points of nasal polyp and congestion score compared to other biologics including anti-IL5/5Rα (mepolizumab ,depemokimab, benralizumab) and anti-IgE (omalizumab) .Greater improvements were also seen with tezepelumab and dupilumab in regards to olfaction as loss of smell score and University of Pennsylvania Smell Identification Test, computerized tomography sinus imaging as Lund Mackay score ,and also the need for surgery or rescue use of systemic corticosteroid . Prospective pragmatic studies are required to directly compare different biologics in type 2 high and low CRSwNP , including effects on the unified airway in patients with severe asthma and CRSwNP, in particular to look at quality of life as well as clinical remission for upper and lower airway outcomes ."

Journal • P3 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL5

Biologic Therapies for Severe Asthma: Current Insights and Future Directions. (PubMed, J Clin Med) - "The current biologics for severe asthma treatment include omalizumab (anti-IgE), mepolizumab and reslizumab (anti-IL-5), benralizumab (anti-IL-5 receptor), dupilumab (anti-IL-4/IL-13), and tezepelumab (anti-TSLP)...Depemokimab is an ultra-long-acting anti-IL-5 antibody with promising results in phase III trials as a twice-yearly biologic for T2-high asthma. Verekitug follows a similar dosing concept, targeting TSLP, but is still undergoing phase II trials. Itepekimab and astegolimab are two anti-IL-33 antibodies that could have a role in the future treatment of severe asthma. Tezepelumab is in a phase III clinical trial for CRSwNP. Besides new drugs, there is still a need for major research into biologics in severe asthma cases, namely with comparative studies, better biomarkers for predicting response, and the determination of optimal treatment duration."

Journal • Review • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Respiratory Diseases • Sinusitis • IL13 • IL33 • IL4 • IL5

Depemokimab Asthma Imaging and Bronchoscopy Sub-Study (clinicaltrials.gov) - P3 | N=150 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Depemokimab in chronic rhinosinusitis with nasal polyps: A turning point or a missed opportunity? (PubMed, Med) - "The ANCHOR-1 and ANCHOR-2 trials of the long-acting anti-interleukin (IL)-5 monoclonal antibody depemokibab in chronic rhinosinusitis with nasal polyposis demonstrated the safety and statistical efficacy of the drug compared to placebo.1 However, its clinical benefits appear limited compared to other biologic therapies. The reduced dosing interval may improve adherence, but further research is needed to identify the most responsive patients."

Journal • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis