depemokimab (GSK3511294) / GSK - LARVOL DELTA

Progress on 14 key opportunities expected to launch 2025-2031 each with PYS potential above £2 billion (GSK Press Release) - "Phase III development programme for depemokimab COPD started with launch of ENDURA studies; Pivotal/Phase III trial starts planned in H2 25 for: potential cancer treatments GSK'227 B7H3 ADC for ES-SCLC and GSK'981 IDRx-42 for 2L GIST; efimosfermin for treatment of MASH"

New P3 trial • Trial status • Chronic Obstructive Pulmonary Disease • Gastrointestinal Stromal Tumor • Metabolic Dysfunction-Associated Steatohepatitis • Small Cell Lung Cancer

Pipeline progress and investment delivering future growth opportunities (GSK Press Release) - "US Approvals now received for...Nucala, anti-IL5 biologic for COPD; Blenrep (for multiple myeloma) approved in EU, Japan, UK, Canada and Switzerland. Constructive discussion ongoing with FDA with new PDUFA date set for 23 October 2025; US regulatory decision on depemokimab (for asthma with type 2 inflammation, nasal polyps) expected in December 2025"

Regulatory • Asthma • Chronic Obstructive Pulmonary Disease • Inflammation • Multiple Myeloma • Nasal Polyps

Targeted Biologic Therapies in Severe Asthma: Mechanisms, Biomarkers, and Clinical Applications. (PubMed, Pharmaceuticals (Basel)) - "Monoclonal antibodies targeting IgE (omalizumab) and IL-5 (mepolizumab, benralizumab, reslizumab, depemokimab) have demonstrated the ability to reduce exacerbation frequency and improve lung function, with newer agents such as depemokimab offering extended dosing intervals. Itepekimab, an anti-IL-33 antibody, effectively engages its target and mitigates tissue eosinophilia, while CM310-stapokibart, tralokinumab, and lebrikizumab inhibit IL-4/IL-13 signaling with variable efficacy depending on patient biomarkers. Comparative analyses of these biologics, encompassing affinity, dosing regimens, and trial outcomes, underscore the imperative of personalized therapy to optimize disease control in severe asthma."

Biomarker • Journal • Review • Asthma • Eosinophilia • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • IL13 • IL17A • IL33 • IL4 • IL5

Depemokimab: Data from P3 NIMBLE trial (NCT04718389) for asthma in H2 2025 (GSK) - Q2 2025 Results: Data from P3 OCEAN trial (NCT05263934) for eosinophilic granulomatosis with polyangiitis in 2026

P3 data • Asthma • Immunology

Depemokimab: Regulatory decisions in EU/China/Japan for severe asthma (based on SWIFT-1 and SWIFT-2 trials) in H1 2026 (GSK) - Q2 2025 Results: Regulatory decisions in EU/China/Japan (based on ANCHOR-1 and ANCHOR-2 trials) for chronic rhinosinusitis with nasal polyps in H1 2026; Launch in US for severe asthma and CRSwNP in 2026

China approval • EMA approval • Japan approval • Launch US • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

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 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

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

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

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

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

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2) (clinicaltrials.gov) - P3 | N=960 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA -1) (clinicaltrials.gov) - P3 | N=981 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

TWICE-YEARLY DEPEMOKIMAB REDUCES NEED FOR BURST ORAL CORTICOSTEROID USE IN PATIENTS WITH ASTHMA: POSTHOC ANALYSES OF THE PHASE III SWIFT-1/2 STUDIES (CHEST 2025) - No abstract available

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

TWICE-YEARLY DEPEMOKIMAB REDUCES EXACERBATIONS IN PATIENTS WITH ASTHMA AND ONLY TWO PRIOR EXACERBATIONS IN THE PAST YEAR: ANALYSIS OF PHASE III SWIFT-1/2 STUDIES (CHEST 2025) - No abstract available

Clinical • P3 data • Asthma • Immunology • Respiratory Diseases

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

Enrollment open • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

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

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