depemokimab (GSK3511294) / GSK - LARVOL DELTA

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

Depemokimab: Data from P3 AGILE trial (NCT05243680) for asthma in H1 2025 (GSK) - Q3 2024 Results: Data from P3 NIMBLE trial (NCT04718389) for asthma in H2 2025

P3 data • Asthma • Immunology

ANCHOR-1: Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (clinicaltrials.gov) - P3 | N=276 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2) (clinicaltrials.gov) - P3 | N=264 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis

GSK announces positive phase III results from ANCHOR trials for depemokimab in chronic rhinosinusitis with nasal polyps (GSK Press Release) - P3 | N=277 | ANCHOR-1 (NCT05274750) | P3 | N=264 | ANCHOR-2 (NCT05281523) | Sponsor: GlaxoSmithKline | "GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III clinical trials ANCHOR-1 and ANCHOR-2, which assessed the efficacy and safety of depemokimab versus placebo in adults with CRSwNP. Both trials met their co-primary endpoints of a change from baseline in total endoscopic nasal polyp score at 52 weeks and change from baseline in mean nasal obstruction score from weeks 49 to 52. The overall incidence and severity of treatment-emergent adverse events across both trials were similar in patients treated with either depemokimab or placebo. Further analysis of these data is ongoing. The full results of ANCHOR-1 and ANCHOR-2 will be presented at an upcoming scientific congress."

P3 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps

NIMBLE: A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=1667 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Late Breaking Abstract - Depemokimab efficacy/safety in patients with asthma on medium/high-dose ICS: The Phase IIIA randomised SWIFT-1/2 studies (ERS 2024) - P3 | "Depemokimab significantly reduced exacerbations and was well tolerated in patients with asthma with type 2 inflammation recognised by blood eosinophil count."

Clinical • Late-breaking abstract • P1/2 data • P3 data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Phase I, single-dose study to compare pharmacokinetics of depemokimab delivered by safety syringe device or autoinjector in healthy adults (ERS 2024) - P1 | "For single-dose depemokimab, PK and bioavailability were similar for SSD and AI; criteria for bioequivalence were met. PK was generally comparable across injection sites. Incidence of immunogenicity and AEs were low and similar for SSD and AI."

Clinical • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Enhanced in vitro potency of depemokimab for interleukin-5 inhibition versus mepolizumab (ERS 2024) - "Depemokimab demonstrated substantially higher potency than mepolizumab for both inhibition of IL-5-mediated proliferation in a human cell line and IgER-mediated human basophil degranulation. Depemokimab's high affinity for IL-5 with resultant enhanced functional potency and prolonged half-life provide a mechanistic basis for understanding its clinical effects. The clinical implications are currently under investigation in randomised controlled trials."

Preclinical • Hematological Malignancies • Leukemia • Oncology • IL5

Depemokimab PK/PD in the 52-week randomised double-blind multicentre Phase III SWIFT-1 trial (ERS 2024) - P3 | "Sustained depemokimab concentration and rapid and sustained BEC suppression, reflecting inflammation biomarkers, support depemokimab as a twice-yearly option for patients with asthma."

Clinical • P3 data • PK/PD data • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

GSK's 'Depemokimab' Promising Asthma Treatment (Medipana) - P3 | N=395 | SWIFT-1 (NCT04719832) | P3 | N=397 | SWIFT-2 (NCT04718103) | Sponsor: GlaxoSmithKline | "GlaxoSmithKline (GSK)'s 'depemokimab' was found to significantly reduce acute exacerbations of severe asthma in phase 3 clinical trials (SWIFT-1 and SWIFT-2 trials)....According to data simultaneously announced in the European Respiratory Society International Congress and the 'New England Journal of Medicine' (NEJM), the annual acute exacerbation rate of depemokimab was reduced by 54% compared to the placebo group...once every 6 months, targets interleukin 5 (IL-5), the main cause of type 2 inflammatory asthma. In the trial, 382 and 380 participants were randomly divided and received standard asthma treatment plus depemokimab or placebo. Both trials achieved their primary endpoints....Based on these clinical results, depemokimab is likely to lead to approval applications from regulatory authorities around the world in the future."

P3 data • Asthma

Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. (PubMed, N Engl J Med) - P3 | "Depemokimab reduced the annualized rate of exacerbations among patients with severe asthma with an eosinophilic phenotype. (Funded by GSK; SWIFT-1 and SWIFT-2 ClinicalTrials.gov numbers, NCT04719832 and NCT04718103.)."

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

Depemokimab: Acceptance of regulatory submissions in EU/China/Japan (based on SWIFT-1 and SWIFT-2 trials) for asthma in H1 2025 (GSK) - Q2 2024 Results: Acceptance of regulatory submissions in EU/China/Japan (based on ANCHOR-1 and ANCHOR-2 trials) for chronic rhinosinusitis with nasal polyps in H1 2025

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

Depemokimab: Regulatory decision in US for asthma (based on SWIFT-1 and SWIFT-2 trials) in H2 2025 (GSK) - Q2 2024 Results: Regulatory decision in US for chronic rhinosinusitis with nasal polyps (based on ANCHOR-1 and ANCHOR-2 trials) in H2 2025

FDA approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Depemokimab: Data from P3 ANCHOR-1 trial (NCT05274750) for chronic rhinosinusitis with nasal polyps in H2 2024 (GSK) - Q2 2024 Results: Data from P3 ANCHOR-2 trial (NCT05281523) for chronic rhinosinusitis with nasal polyps in H2 2024

P3 data • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Depemokimab: Data from P3 AGILE trial (NCT05243680) for asthma in 2025 (GSK) - Q2 2024 Results: Data from P3 NIMBLE trial (NCT04718389) for asthma in 2025

P3 data • Asthma • Immunology

An Open-Label Extension Study of GSK3511294 (Depemokimab) in Participants Who Were Previously Enrolled in 206713 (NCT04719832) or 213744 (NCT04718103) (clinicaltrials.gov) - P3 | N=643 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

SWIFT-2: A Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=397 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases