depemokimab (GSK3511294) / GSK - LARVOL DELTA

Depemokimab reduces exacerbations in severe asthma versus other biologics: A multilevel network meta-regression (ERS 2025) - "Depemokimab showed a statistically significant reduction in the risk of clinically significant exacerbations across all models versus placebo, against benralizumab, dupilumab (300 mg) and omalizumab in unadjusted models, and against omalizumab in partially adjusted models (Figure). No significant differences were observed between depemokimab and dupilumab 200 mg/mepolizumab/reslizumab/tezepelumab. Our results show no statistically significant differences in annual exacerbation rates across assessed biologics, suggesting comparable benefits for asthma. Funding: GSK (212680)."

Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

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

Does frequency matter to patients? Views on current and upcoming severe asthma biologics (ERS 2025) - "This study provides a previously unknown insight into severe asthma patient views on the upcoming 6-monthly biologic Depemokimab, thus aiding onward clinical management."

Clinical • 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) - P3 | "Depemokimab reduces exacerbations versus placebo in patients with type 2 asthma across asthma onset age and duration subgroups with greatest reduction for patients with duration <10 years, supporting earlier biologic initiation. Funding: GSK (206713/213744; NCT04719832/NCT04718103)."

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

Twice-yearly depemokimab demonstrates sustained pharmacokinetics and pharmacodynamics across Phase I and III trials (ERS 2025) - P1, P3 | "Depemokimab demonstrates extended PK and durable PD, supporting sustained inflammation suppression and twice-yearly dosing with no dose adjustments based on in/extrinsic factors. Funding: GSK (205722/208021/214099/206713/213744/217095/218079; NCT03287310/NCT05140200/NCT05602025/NCT04 719832/NCT04718103/NCT05274750/NCT05281523)."

P1 data • PK/PD data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL5

Clinical remission in patients with asthma treated with twice-yearly depemokimab in the Phase III SWIFT-1/2 studies (ERS 2025) - P3 | "In patients with type 2 asthma, a greater proportion of patients achieved CR with depemokimab vs placebo, with the largest proportion seen in the disease duration <10 years subgroup, supporting earlier biologic initiation. Funding: GSK (206713/213744; NCT04719832/NCT04718103)."

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

Twice-yearly depemokimab is well-tolerated in randomised, double-blind, placebo-controlled Phase III SWIFT and ANCHOR studies (ERS 2025) - P3 | "Twice-yearly depemokimab is well-tolerated in patients with asthma or CRSwNP, supporting safety of the first ultra-long-acting biologic in these populations. Funding: GSK 206713/213744/217095/218079; NCT04719832/NCT04718103/NCT05281523/NCT05274750."

Clinical • P3 data • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • Sinusitis • IL5

Geographic variation in outcomes in RCTs of biologic therapies in patients with asthma or COPD: A systematic literature review (ERS 2025) - "Background: Geographic variation in exacerbation reductions has been reported in several RCTs, most recently in Phase III SWIFT-1/2 trials of depemokimab, an ultra-long-acting biologic enabling twice-yearly dosing for asthma, with high placebo response in Eastern Europe... Exacerbations by geography were reported in 4 asthma RCTs and 1 OLE, with smaller treatment effects seen in Eastern Europe for most biologics versus placebo; 2 COPD RCTs showed a smaller treatment effect of dupilumab on exacerbations in Eastern Europe versus other regions ( Figure ). Geographic variation in outcomes was observed across biologic therapies in asthma or COPD RCTs and OLEs, with lower treatment effects in Eastern Europe and higher treatment effects in Asia Pacific (asthma only) versus other regions. Funding: GSK (223319)."

Clinical • Review • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • 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) - P3 | "Depemokimab reduces exacerbations in patients with asthma across baseline ICS dose subgroups, supporting potential initiation prior to ICS escalation. Funding: GSK (206713/213744; NCT04719832/NCT04718103)."

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

Depemokimab is associated with early and sustained improvements in patient-reported outcomes in CRSwNP: Data from the ANCHOR-1/2 trials (ERS 2025) - P3 | "Twice-yearly depemokimab provided early and sustained improvements in nasal obstruction and loss of smell, two cardinal and burdensome symptoms of severe CRSwNP. Funding: GSK (217095/218079; NCT05281523/NCT05274750)."

Clinical • Patient reported outcomes • Chronic Rhinosinusitis With Nasal Polyps • Inflammation • IL5

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) - P3 | "Twice-yearly depemokimab, compared with placebo, reduced clinically significant asthma exacerbations in patients with type 2 asthma and comorbid CRSwNP. This reduction was greater than the exacerbation rate reduction observed in the overall asthma population of the SWIFT-1/2 studies. Funding: GSK (206713/213744; NCT04719832/NCT04718103)."

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

Model-based comparison of eosinophilic depletion following treatment with benralizumab mepolizumab and depemokimab (ACAAI 2025) - No abstract available

VIGILANT: eValuating the Efficacy and Safety of InitiatinG depemokImab earLy therApy iN Chronic Obstructive Pulmonary Disorder (COPD) With Type 2 Inflammation (clinicaltrials.gov) - P3 | N=1196 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Presentation of data from the ANCHOR-1 and ANCHOR-2 trials in CRSwNP (GSK Press Release) - "GSK...will present the latest research from across its respiratory portfolio at the upcoming ERS Congress 2025...Presentation...will explore the potential impact of depemokimab on early and sustained improvements in patient reported outcomes (OA2335)."

P3 data • Patient reported outcomes • Chronic Rhinosinusitis With Nasal Polyps

Additional data from SWIFT-1 and SWIFT-2 (GSK) - "GSK...will present the latest research from across its respiratory portfolio at the upcoming ERS Congress 2025...Presentation...will explore the potential for depemokimab to achieve clinical remission in asthma patients with type 2 inflammation, with the aim to advance treatment goals beyond symptom control (PA2478)."

P3 data • Asthma • Immunology • Inflammation

Sub-analyses from the SWIFT-1 and SWIFT-2 trials (GSK Press Release) - "GSK...will present the latest research from across its respiratory portfolio at the upcoming ERS Congress 2025...Asthma patient sub-groups include those with comorbid CRSwNP, an important population as up to 40% of severe asthma patients also have CRSwNP (OA2334), and patients requiring medium- or high-dose inhaled corticosteroids (ICS) at baseline (PA2469)."

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

Twice-Yearly Depemokimab Improves Peak Expiratory Flow and Rescue Inhaler Use in Patients with Asthma: SWIFT-1/2 (ACAAI 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

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

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: “The committee discussed the issues identified in this application”; Chronic rhinosinusitis with nasal polyps (European Medicines Agency) - CHMP Final Minutes of the meeting on 19 - 22 May 2025: “The committee adopted the CHMP recommendation and scientific discussion together with the list of questions”

CHMP • Chronic Rhinosinusitis With Nasal Polyps • Immunology

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

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

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 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