depemokimab (GSK3511294) / GSK - LARVOL DELTA

Twice-Yearly Depemokimab Efficacy is Sustained Across Seasons in Patients with Asthma: Analyses of Pooled Phase III SWIFT-1/2 Studies (EAACI 2025) - No abstract available

Clinical • P3 data • Immunology

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) - No abstract available

Clinical • Immunology

Model-based Comparison of the Pharmacokinetic/Pharmacodynamic and Eosinophilic Response of Benralizumab Versus Depemokimab at 12 Weeks (ATS 2025) - No abstract available

PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

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) - No abstract available

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

Twice-Yearly Depemokimab Demonstrates Efficacy in Patients With Asthma in China and Japan: Subpopulation Analyses of the SWIFT-1/2 Studies (ATS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

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) - No abstract available

Clinical • P3 data • Asthma • Immunology • Respiratory Diseases

GSK announces positive results for depemoximab in patients with chronic rhinosinusitis and nasal polyps (GSK Press Release) - P3 | N=277 | ANCHOR-1 (NCT05274750) | P3 | N=264 | ANCHOR-2 (NCT05281523) | Sponsor: GlaxoSmithKline | "...depemoximab administered once every six months (26 weeks) met its primary endpoints by demonstrating clinically meaningful, statistically significant improvements compared to placebo in two important clinical measures of disease severity: nasal polyp size and nasal congestion. Additionally , a pooled analysis of the two studies showed improvements (reductions) from baseline in the following measures compared to placebo: Nasal polyp score (NPS, 0-8) at 52 weeks (treatment difference [95% CI]: -0.7 [-0.9, -0.4], nominal p<0.001). Mean nasal congestion score (verbal response scale (VRS, 0-3)) at weeks 49-52 (treatment difference [95% CI]: -0.24 [-0.39, -0.08], nominal p=0.003)."

P3 data • Chronic Rhinosinusitis With Nasal Polyps

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) - No abstract available

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

Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP) (GSK Press Release) - "GSK plc...today announced the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application for the use of depemokimab in two indications...The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)....Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results from the SWIFT and ANCHOR trials....The Prescription Drug User Fee Act (PDUFA) date is 16 December 2025."

FDA filing • PDUFA • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation

Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials. (PubMed, Lancet) - P3 | "Depemokimab significantly improved clinically relevant coprimary endpoints versus placebo and was well tolerated, supporting its use as a twice per year treatment option, with the potential to reduce treatment burden for people with CRSwNP."

Journal • P3 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • 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: Nov 2025 ➔ Apr 2026 | Trial primary completion date: Oct 2025 ➔ Mar 2026

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

Depemokimab Reduces Exacerbations in Patients With Type 2 Asthma Characterized by Blood Eosinophils Across a Range of Blood Eosinophil and IgE Levels: SWIFT Subgroup Analyses (AAAAI-WAO 2025) - P3 | "No clinically relevant difference was observed for ACQ-5 or FEV 1 in any BEC/baseline IgE subgroup. Conclusions Twice-yearly depemokimab consistently reduced exacerbations versus placebo in patients with T2 asthma across a range of baseline T2 biomarker levels."

Clinical • Late-breaking abstract • Asthma • Immunology • Respiratory Diseases • IL5

Twice-Yearly Depemokimab Demonstrates an Acceptable Safety Profile in a 12-Month Interim Analysis of the AGILE Phase III Open-Label Extension Study (AAAAI-WAO 2025) - P3 | "The annualized exacerbation rate (95% confidence interval) was 0.47 (0.40, 0.56) overall and 0.46 (0.38, 0.56)/0.48 (0.37, 0.63) for patients previously receiving depemokimab/placebo, respectively. Conclusions In this interim analysis, long-term depemokimab was well-tolerated, with safety and efficacy profiles consistent with those in SWIFT-1/2 studies, demonstrating sustained efficacy for patients remaining on depemokimab."

Clinical • Late-breaking abstract • P3 data • P3 data: top line • Asthma • Dermatology • Immunology • Infectious Disease • Pruritus • Respiratory Diseases • IL5

Pharmacokinetics and Pharmacodynamics of Twice-Yearly Depemokimab in the Randomized, Double-Blind, Placebo-Controlled Parallel Phase III ANCHOR-1/2 Trials (AAAAI-WAO 2025) - P3 | "Conclusions Two doses of depemokimab achieved sufficient concentrations to effectively suppress BEC over 52 weeks, reflecting sustained anti–IL-5 biological effect and impact on type 2 inflammation. These findings support depemokimab as a twice-yearly option for patients with CRSwNP."

Clinical • Late-breaking abstract • P3 data • PK/PD data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL5

Efficacy and Safety of Twice-Yearly Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP): The Phase III Randomized, Double-Blind, Placebo-Controlled Replicate ANCHOR-1/2 Trials (AAAAI-WAO 2025) - P3 | "Similar proportions of depemokimab-treated patients experienced AEs/SAEs versus placebo (AEs: ANCHOR-1, 74% vs 79%; ANCHOR-2, 76% vs 80%; SAEs: ANCHOR-1, 3% vs 5%; ANCHOR-2, 5% vs 8%). Conclusions The efficacy of twice-yearly depemokimab in significantly improving clinically relevant coprimary endpoints was demonstrated in ANCHOR-1/2, while exhibiting a well-tolerated safety profile."

Clinical • Late-breaking abstract • P3 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL5

Depemokimab: Acceptance of regulatory submission in US (based on ANCHOR-1 and ANCHOR-2 trials) for chronic rhinosinusitis with nasal polyps in H1 2025 (GSK) - Q4 & FY2024 Results: Regulatory decision in US (based on ANCHOR-1 and ANCHOR-2 trials) for chronic rhinosinusitis with nasal polyps in H2 2025; Regulatory decisions in EU/China/Japan (based on ANCHOR-1 and ANCHOR-2 trials) for chronic rhinosinusitis with nasal polyps in 2026

China approval • EMA approval • FDA approval • FDA filing • Japan approval • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Depemokimab: Acceptance of regulatory submission in US for severe asthma (based on SWIFT-1 and SWIFT-2 trials) in H1 2025 (GSK) - Q4 & FY2024 Results: Regulatory decision in US for severe asthma (based on SWIFT-1 and SWIFT-2 trials) in H2 2025; Regulatory decisions in EU/China/Japan for severe asthma (based on SWIFT-1 and SWIFT-2 trials) in 2026

China approval • EMA approval • FDA approval • FDA filing • Japan approval • Asthma • Immunology

Pharmacokinetics of Depemokimab Delivered by Safety Syringe Device or Autoinjector in Healthy Adults: A Phase I, Single-Dose Study. (PubMed, Clin Pharmacol Drug Dev) - "Treatment-related adverse events were reported in 19% of SSD and 20% of AI participants, with headache being the most common across both arms; no adverse events led to study withdrawal. These results support the use of either SSD or AI for subcutaneous administration of depemokimab."

Journal • PK/PD data • Pain • IL5

Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP (GSK Press Release) - "GSK plc...announced that new drug applications have been accepted for review by the China National Medical Products Administration and submitted to the Japanese Ministry of Health, Labour and Welfare for use of depemokimab in two indications. In China, the submitted indications are for an add-on maintenance treatment of asthma in adult and adolescent patients aged 12 and older with type 2 inflammation characterised by blood eosinophil count, and add-on maintenance treatment of adult patients with inadequately controlled CRSwNP. In Japan, the submitted indications are for treatment of severe or refractory bronchial asthma and CRSwNP inadequately controlled with standard treatment....Submissions based on data from positive SWIFT and ANCHOR trials."

China filing • Japan filing • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation

Depemokimab accepted for review by the European Medicines Agency for use in asthma with type 2 inflammation and CRSwNP (GSK Press Release) - "The submitted indications are for add-on maintenance treatment of asthma in adult and adolescent patients aged 12 years and older with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on medium to high dose corticosteroids (ICS) plus another asthma controller and also as an add-on treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps...The phase III asthma programme consists of SWIFT-1 and SWIFT-2 in asthma with type 2 inflammation, with an open label extension study (AGILE)....The phase III programme in CRSwNP includes two studies, ANCHOR-1 and ANCHOR-2."

EMA filing • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation

DESTINY: Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Mar 2026 ➔ Nov 2026 | Trial primary completion date: Feb 2026 ➔ Nov 2026

Trial completion date • Trial primary completion date • Hypereosinophilic Syndrome • Immunology

In severe asthma with an eosinophilic phenotype, depemokimab improved exacerbations, but not quality of life, at 52 wk. (PubMed, Ann Intern Med) - "GIM/FP/GP: [Formula: see text] Allerg & Immunol: [Formula: see text] Pulmonology: [Formula: see text]."

Clinical • HEOR • Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Depemokimab: Launch for severe eosinophilic asthma and chronic rhinosinusitis with nasal polyps in 2025/2026 (GSK) - Early Pipeline: Launch for eosinophilic granulomatosis with polyangiitis in 2027; Launch for COPD in 2029 or later

Launch • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilic Granulomatosis With Polyangiitis • Immunology

Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody for severe eosinophilic asthma. (PubMed, Med) - "Depemokimab, the first ultra-long-acting anti-IL-5 monoclonal antibody, significantly reduced exacerbation rates in patients with severe eosinophilic asthma when administered biannually.1 While it offers potential benefits for patient adherence and convenience, the trials showed no improvement in symptoms and lung function. Further research is needed to determine its optimal place in therapy and identify patients who will benefit the most."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Drugs for asthma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases