Exdensur (depemokimab-ulaa) / GSK - LARVOL DELTA

Depemokimab: First Approval. (PubMed, Drugs) - "Add-on treatment with depemokimab reduced asthma-related exacerbations in patients with severe asthma with an eosinophilic phenotype, in addition to reducing the severity of nasal polyps and nasal obstruction in patients with CRSwNP. This article summarizes the milestones in the development of depemokimab leading to this first approval in the UK as an add-on maintenance treatment of asthma in adult and adolescent patients aged ≥ 12 years with type 2 inflammation characterised by an eosinophilic phenotype who are inadequately controlled on maximum moderate-dose or high-dose inhaled corticosteroids plus another asthma controller; and as add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis With Nasal Polyps • Eosinophilic Granulomatosis With Polyangiitis • Hypereosinophilic Syndrome • Immunology • Inflammation • Langerhans Cell Histiocytosis • Nasal Polyps • Otorhinolaryngology • Pulmonary Disease • Rare Diseases • Respiratory Diseases • Sinusitis • Vasculitis • IL5

Depemokimab demonstrates efficacy in patients with type 2 asthma with comorbid CRSwNP: Phase III SWIFT-1/-2 analysis. (PubMed, Front Allergy) - P3 | "These findings identify that type 2 asthma with CRSwNP is a clinically recognizable phenotype that is likely to have enhanced benefit with depemokimab therapy. NCT04719832/NCT04718103."

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

Twice-Yearly Depemokimab Improves Symptoms and Quality of Life in Patients with CRSwNP with Post-Surgical Recurrence and Multiple Indicators of Type 2 Inflammation: Post Hoc Analysis of ANCHOR-1/-2 (EAACI 2026) - No abstract available

Clinical • HEOR • Retrospective data • Immunology • Inflammation

Twice-Yearly Depemokimab Maintains Exacerbation Reduction Over 2 Years in Patients with Asthma Regardless of Prior Exacerbation History: An Integrated Analysis of the SWIFT-1/-2 and AGILE Studies (EAACI 2026) - No abstract available

Clinical • Allergy • Immunology

Patients with Inadequately Controlled CRSwNP and Blood Eosinophil Count ≥150 cells/µL Experience Benefit with Depemokimab: An Analysis of Data from the Integrated ANCHOR-1/-2 Studies (EAACI 2026) - No abstract available

Clinical • Immunology

EUFOREA/EPOS Criteria Applied to a Diverse CRSwNP Cohort: Post Hoc Findings from Twice-Yearly depemokimab ANCHOR-1/-2 trials (EAACI 2026) - No abstract available

Retrospective data • Immunology

Depemokimab (Exdensur) for severe eosinophilic asthma. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

MODIFY: A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma (clinicaltrials.gov) - P3 | N=456 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Pulmonary Disease • Respiratory Diseases

Twice-Yearly Depemokimab Delivers Clinically Meaningful Improvements in Patients With CRSwNP With Features of T2 inflammation and Disease Recurrence Following Surgery: Post Hoc Pooled Analysis of ANCHOR-1/-2 (AAAAI 2026) - "Depemokimab demonstrated higher responder rates versus placebo for NO VRS (46% vs 21%; OR [95% CI]: 2.82 [1.37, 5.78]; p=0.006), LoS VRS (29% vs 15%; OR: 2.35 [0.99, 5.60]; p=0.054), SNOT-22 (65% vs 43%; OR: 2.25 [1.15, 4.39]; p=0.019), and NP (41% vs 25%; OR: 2.04 [0.99, 4.20]; p=0.053) scores, and lower rates for rescue intervention use (19% vs 37%; OR: 0.34 [0.16, 0.75]; p=0.008). Conclusions Despite limited patient numbers, twice-yearly depemokimab led to clinically meaningful improvements in symptoms and QoL while reducing rescue intervention needs in patients with CRSwNP recurrence, offering a promising treatment option with reduced dosing frequency."

Late-breaking abstract • Retrospective data • Surgery • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Inflammation • Respiratory Diseases • IL5

Blood Eosinophil Counts Are Positively Correlated with T2 Cytokine (IL-4, IL-5, and IL-13) Levels in Patients with CRSwNP: Pooled Post Hoc Analysis of Data from ANCHOR-1/-2 Studies (AAAAI 2026) - P1 | "This post hoc analysis assessed the relationship between BEC and T2 cytokine levels in patients with CRSwNP from the Phase III ANCHOR-1/-2 trials of depemokimab, the first ultra-long-acting biologic with enhanced IL-5 binding affinity, high potency, and extended half-life, enabling sustained suppression of T2 inflammation with twice-yearly dosing in patients with CRSwNP...Conclusions BEC positively and significantly correlated with IL-4, IL-5, and IL-13, highlighting the value of BEC as a T2 inflammation biomarker. These cytokines were also elevated at baseline in patients with CRSwNP versus HVs."

Clinical • Late-breaking abstract • Retrospective data • Chronic Rhinosinusitis With Nasal Polyps • Inflammation • IL13 • IL4 • IL5

Long-Term Safety and Efficacy of Depemokimab in Patients with Type 2 Asthma: A Single-Arm, Open-Label Extension Study (AGILE) (AAAAI 2026) - P3 | "These findings support the long-term safety and efficacy of depemokimab in asthma. Funding GSK (212895/NCT05243680)."

Clinical • Asthma • Immunology • Respiratory Diseases • IL5

Twice-Yearly Depemokimab Improved Nasal Polyp Burden and Nasal Obstruction in Chinese Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): Subpopulation Analysis of Phase 3 ANCHOR-1/2 Trials (AAAAI 2026) - P3 | "In integrated analysis, participants on depemokimab and placebo reported similar incidences of on-treatment adverse events (68% [23/34] vs. 86% [25/29]) and serious adverse events (3% [1/34] vs. 14% [4/29]). Conclusions Twice-yearly depemokimab improved co-primary endpoints versus placebo and was well-tolerated in Chinese individuals with CRSwNP, consistent with global findings."

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

Depemokimab Improved Nasal Polyp Score, Symptoms and Quality of Life in Patients with CRSwNP Who Had Disease Recurrence Following One Surgery and Indicators of Type 2 Inflammation: Post Hoc Pooled Analysis of ANCHOR-1/2 (AAAAI 2026) - "Depemokimab versus placebo significantly improved NPS (LS mean CFB [SE]: -0.6[0.18] versus 0.0[0.19]; treatment difference [95% CI]: -0.6[-1.1,-0.1],p=0.023); NO-VRS score (-0.87[0.099] versus -0.46[0.103]; difference: -0.41[-0.69,-0.13],p=0.006), LoS-VRS score (-0.57[0.093] versus -0.26[0.097]; difference: -0.31[-0.58,-0.05],p=0.022) and total SNOT-22 score (-17.2[3.68] versus -5.8[3.81]; difference: -11.4[-21.9,-0.9],p=0.035). Conclusions Twice-yearly depemokimab versus placebo improved NPS, key symptoms and quality of life in patients with CRSwNP who had one surgery and indicators of T2 inflammation, supporting its potential use in this population commonly considered for biologic therapy."

HEOR • Retrospective data • Surgery • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology • Inflammation • Nasal Polyps • Otorhinolaryngology • Respiratory Diseases • IL5

Depemokimab vs Mepolizumab: Immuno-PET Imaging to Evaluate the Impact of YTE Modification on Tissue Distribution in Cynomolgus Monkeys (ATS 2026) - No abstract available

Inflammation • Respiratory Diseases

Efficacy and Safety of Twice-yearly Depemokimab in Adolescent Patients With Asthma: Subgroup Analysis of the Swift-1/-2 Studies (ATS 2026) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Twice-yearly Depemokimab Is Well Tolerated Over 2 Years in Patients With Type 2 Asthma: An Integrated Safety Analysis of the Phase III SWIFT-1/-2 and the Open-label Extension AGILE Studies (ATS 2026) - No abstract available

Clinical • P3 data • Asthma • Immunology • Respiratory Diseases

Depemokimab Demonstrates Sustained Long-term Efficacy and Consistent Patient-reported Outcomes Over 2 Years in Patients With Type 2 Asthma and Chronic Rhinosinusitis With Nasal Polyps: An Integrated Analysis of the Phase III SWIFT-1/-2 and the Open-label Extension AGILE Studies (ATS 2026) - No abstract available

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

Depemokimab Demonstrates Sustained Long-term Efficacy and Consistent Patient-reported Outcomes Over 2 Years in Patients With Type 2 Asthma: An Integrated Analysis of the SWIFT-1/-2 and AGILE Studies (ATS 2026) - No abstract available

Clinical • Patient reported outcomes • Asthma • Immunology • Respiratory Diseases

Depemokimab Demonstrates Sustained Long-term Efficacy and Consistent Patient-reported Outcomes Over 2 Years in Patients With Type 2 Asthma Irrespective of Baseline Inhaled Corticosteroid Dose: An Integrated Analysis of the Phase III SWIFT-1/-2 and the Open-label Extension AGILE Studies (ATS 2026) - No abstract available

Clinical • P3 data • Patient reported outcomes • Asthma • Immunology • Respiratory Diseases

222725: Depemokimab as an Extended treatmeNt DURation biologic in Adults with COPD and type 2 inflammation (ENDURA-1). (clinicaltrialsregister.eu) - P2/3 | N=327 | Recruiting | Sponsor: Glaxosmithkline Research & Development Limited

New P2/3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A phase 3b study of depemokimab on airway structure and function in patients with type 2 asthma utilizing quantitative high-resolution CT and a bronchoscopic airway sampling sub study (clinicaltrialsregister.eu) - P2/3 | N=55 | Recruiting | Sponsor: Glaxosmithkline Research & Development Limited

New P2/3 trial • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

222714: Depemokimab as an Extended treatmeNt DURation biologic in Adults with COPD and type 2 inflammation (ENDURA-1). (clinicaltrialsregister.eu) - P2/3 | N=453 | Recruiting | Sponsor: Glaxosmithkline Research & Development Limited

New P2/3 trial • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Switching to twice-yearly depemokimab from mepolizumab/benralizumab in severe asthma: A multicenter, randomized, double-blind, Phase 3A Clinical Trial (NIMBLE). (PubMed, Am J Respir Crit Care Med) - P3 | "While statistical non-inferiority was not met, exacerbation rates were low and symptom control/lung function were maintained in both groups. This first randomized, controlled switch trial in severe asthma suggests that participants with severe asthma on mepolizumab or benralizumab may safely switch to twice-yearly depemokimab."

Clinical • Journal • P3 data • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL5

Exdensur (depemokimab) approved by the European Commission for severe asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (GSK Press Release) - "GSK plc (LSE/NYSE: GSK) today announced the European Commission has approved Exdensur (depemokimab) in two indications: as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high dose inhaled corticosteroids (ICS) plus another asthma controller; as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control. The approval is based on data from the SWIFT and ANCHOR phase III trials..."

EMA approval • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Inflammation

Comorbid Chronic Rhinosinusitis and Asthma: Shared Risk Factors and Treatment Implications-An EAACI Task Force Report. (PubMed, Allergy) - "It also evaluates current therapeutic strategies such as biologics, aspirin therapy after desensitization (ATAD), and endoscopic sinus surgery (ESS)...Dupilumab, mepolizumab, depemokimab, and omalizumab have emerged as transformative therapies, particularly for patients with severe type 2 inflammation...Itepekimab has shown its effect in asthma and is under investigation for CRSwNP...The report highlights gaps in the literature, such as the lack of head-to-head trials comparing biologics, ATAD, and surgery. Future research should focus on refining treatment algorithms, identifying biomarkers for treatment selection, and assessing long-term outcomes to optimize care for patients with CRS, asthma, and N-ERD."

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