depemokimab (GSK3511294) / GSK - LARVOL DELTA

Exdensur (depemokimab) received a positive opinion from the CHMP for the treatment of a particular type of asthma called severe eosinophilic asthma, and for severe chronic rhinosinusitis with nasal polyps, an inflamed lining of the nose and sinuses with swellings in the nose. (European Medicines Agency)

CHMP • Asthma • Chronic Rhinosinusitis With Nasal Polyps • Immunology

Efficacy and safety of Depemokimab in asthma with eosinophilic phenotype: a systematic review and meta-analysis of randomized controlled trials. (PubMed, BMC Immunol) - "Depemokimab demonstrates promising efficacy in reducing clinically significant exacerbations and improving quality of life measures in patients with severe eosinophilic asthma, with a generally favorable safety profile. However, the current evidence is limited to two trials with relatively short follow-up periods. Further research with larger, more diverse patient populations and extended long-term follow-up is needed to establish the drug's definitive place in therapeutic algorithms and to comprehensively evaluate potential long-term safety concerns before widespread clinical implementation can be recommended."

Journal • Retrospective data • Allergic Rhinitis • Asthma • Back Pain • Immunology • Infectious Disease • Inflammation • Musculoskeletal Pain • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • IL5

Twice-yearly depemokimab efficacy is sustained across seasons in patients with asthma: analyses of pooled phase III SWIFT-1/2 studies (BTS WM 2025) - "Reference Celis-Preciado C, et al. European Respiratory Journal 2025 May."

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

Development of a multi-modal model to predict asthma outcomes using digital monitoring tools (BTS WM 2025) - "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 1 ). Download figure Open in new tab Download powerpoint Abstract P201 Figure 1 Annualised exacerbation rate reductions in patients receiving depemokimab versus placebo were consistent across spring, autumn and winter, with a lower magnitude of reduction in summer due to reduced exacerbation rates in the placebo group 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."

Biomarker • Asthma • Immunology • Inflammation • Respiratory Diseases • IL5

Twice-yearly depemokimab demonstrates efficacy in patients with asthma across baseline medium- and high-dose ICS subgroups: Phase III SWIFT-1/2 studies (BTS WM 2025) - P3 | "Funding GSK (206713/213744; NCT04719832 /NCT04718103). Download figure Open in new tab Download powerpoint Abstract S135 Figure 1 (A) Annualised exacerbation rate and (B) LS mean change from baseline to Week 52 in SGRQ total score in patients receiving depemokimab or placebo stratified by baseline ICS dose (medium/high)"

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

Severe asthma patient perceptions and preferences on the frequency of biologic administration; including opinions on upcoming 6 monthly biologic (BTS WM 2025) - "Concerns related to side effects, cost, and appointment accessibility were more frequently associated with monthly treatment. View this table: View inline View popup Download powerpoint Abstract P131 Table 1 Conclusion This study provides a previously unknown insight into severe asthma patient views on their preferred frequency of biologic administration and seems to suggets an appetite for engagement with an upcoming 6-monthly biologic Depemokimab."

Clinical • Asthma • Immunology • Respiratory Diseases

Drop ANCHOR with Depemokimab or sail to the WAYPOINT with Tezepelumab: A Bucher indirect treatment comparison. (PubMed, Ann Allergy Asthma Immunol) - No abstract available

Journal • Chronic Rhinosinusitis With Nasal Polyps

DESTINY: Depemokimab in Participants With Hypereosinophilic Syndrome, Efficacy, and Safety Trial (clinicaltrials.gov) - P3 | N=123 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Nov 2026 ➔ Dec 2028 | Trial primary completion date: Nov 2026 ➔ Dec 2028

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

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 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

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

Twice-Yearly Depemokimab Improves Peak Expiratory Flow and Asthma Symptoms (Pharmacy Times) - "The findings indicated that depemokimab was associated with greater improvements in least squares mean change from baseline in morning PEF compared with placebo from week 1 to 2 (18.08 [95% CI, 14.16–22.01] vs 9.07 [95% CI, 3.65–14.48] L/min, respectively), with an overall treatment difference of about 9.02 (95% CI, 2.31–15.72). Of note, improvement was sustained until weeks 51 to 52 (23.66 [95% CI, 17.64–29.67] vs 7.81 [95% CI, 0.54–16.16], respectively), with a treatment difference of about 15.84 (95% CI, 5.54–26.15)."

P3 data • Asthma

Comparative Analysis of Patient-Reported Outcomes (PROs) in Asthma Biologic Late-Phase Studies and Approved Labels: Implications for Entry and Product Differentiation (ISPOR-EU 2025) - "This analysis aims to inform endpoint selection for future clinical development and labelling. A review of FDA and EMA labels, regulatory feedback, health authority reviews, and pivotal trial designs was conducted for approved asthma biologics (omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab) and trial designs for late phase studies (depemokimab, dexpremispexole) in May 2025. ACQ-5 and AQLQ responder and change from baseline endpoints are established entry criteria for asthma biologics, with regulatory precedent supporting their inclusion. Symptom diary endpoints and other novel endpoints addressing patient-prioritized outcomes offer opportunities for differentiation. This review provided cross-asset competitive and regulatory intelligence supporting strategic clinical design for best-in-class labelling."

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

Efficacy of Biologics in Patients with Severe Uncontrolled Chronic Rhinosinusitis with Nasal Polyps (ACAAI 2025) - "Results Nine phase 3 RCTs of six biologics (dupilumab, omalizumab, mepolizumab, benralizumab, depemokimab, tezepelumab) were included. Conclusion Among patients with severe, uncontrolled CRSwNP, efficacy varied between biologics across clinical endpoints. Although comparisons across studies should be interpreted with caution, these results can help inform providers’ treatment decisions."

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

Twice-Yearly Depemokimab Improves Peak Expiratory Flow and Rescue Inhaler Use in Patients with Asthma: SWIFT-1/2 (ACAAI 2025) - P3 | "Conclusions Depemokimab improved morning PEF and showed favorable trends in daily asthma symptoms versus placebo, supporting early and sustained symptom control across the dosing interval. Funding GSK (206713/213744; NCT04719832/NCT4718103)."

Clinical • Asthma • Immunology • Respiratory Diseases • IL5

Model-based comparison of eosinophilic depletion following treatment with benralizumab mepolizumab and depemokimab (ACAAI 2025) - "Conclusion These PK/PD model simulations predict that benralizumab results in consistently higher bEOS depletion than mepolizumab or depemokimab at 12 and 24 weeks. These results are dependent on the quality of the models and digitized data utilized; other models and parameter estimates may produce different results."

Asthma • Immunology • Respiratory Diseases • 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=163 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Eosinophilic Granulomatosis With Polyangiitis • Immunology • Langerhans Cell Histiocytosis • Rare Diseases • Vasculitis • MPO

EVOLUTION OF ASTHMA PATIENTS IN RANDOMIZED CLINICAL TRIALS SETTING ALONGSIDE THE CHANGING LANDSCAPE OF BIOLOGIC USE: A COMPARATIVE ASSESSMENT (CHEST 2025) - P3 | " A review of published literature was conducted across asthma populations receiving biologics in the following pivotal Phase III RCTs with exacerbation as the primary endpoint: SWIFT-1 (N=382; 2021–2023) and SWIFT-2 (N=380; 2021– 2024) for depemokimab (anti-IL-5); MENSA (N=576; 2012–2014) and MUSCA (N=551; 2014–2015) for mepolizumab (anti-IL- 5); CALIMA (N=1306; 2013–2015) and SIROCCO (N=1204; 2013–2015) for benralizumab (anti-IL-5Rα); QUEST (N=1903; 2015–2016) and VENTURE (N=210; 2015–2017) for dupilumab (anti-IL-4Rα); and NAVIGATOR (N=1059; 2017–2020) for tezepelumab (anti-thymic stromal lymphopoietin [anti-TSLP]). The SWIFT-1/2 populations reflect the evolution of the biologic landscape for asthma. Key differences in the SWIFT-1/2 populations compared with previous trials include lower number of prior exacerbations, lower proportion of patients receiving mOCS at baseline, longer duration of asthma (with a broad distribution across countries) and lower ACQ scores..."

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

Depemokimab: a new long-acting anti-IL5 treatment for severe asthma and chronic rhinosinusitis with nasal polyps. (PubMed, Curr Opin Allergy Clin Immunol) - "Depemokimab could offer patients with severe persistent asthma a more convenient add-on treatment option than existing shorter acting biologics and thereby improve overall adherence."

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

Depemokimab: Data from P3 OCEAN trial (NCT05263934) for eosinophilic granulomatosis with polyangiitis in H2 2026 (GSK) - Q3 2025 Results

P3 data • Eosinophilic Granulomatosis With Polyangiitis • Immunology

Depemokimab: Launch in US for severe asthma and CRSwNP in 2026 (GSK) - Q3 2025 Results

Launch US • Chronic Rhinosinusitis With Nasal Polyps • Immunology

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) - P3 | "Depemokimab treatment was associated with fewer patients experiencing exacerbations requiring burst OC treatment versus placebo and a smaller number of days with burst OCS per patient versus placebo. CLINICAL IMPLICATIONS: This analysis supports the timely initiation of biologics such as depemokimab in patients wit asthma to reduce exacerbations and the need for recurrent OCS bursts. FUNDING: GSK (206713/213744; NCT04719832/NCT04718103)."

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

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) - P3 | "Depemokimab showed clinical benefit for patients with asthma across prior exacerbation subgroups. While patients with >2 prior exacerbations experienced a higher relative exacerbation reduction, patients with only 2 prior exacerbations at baseline were more likely to be exacerbation-free and also benefited from timely biologic intervention. CLINICAL IMPLICATIONS: These data support the use of depemokimab in patients with a less frequent exacerbation history and the timely initiation of biologics in this population, as evidenced by the clinical benefit shown."

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

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

NIMBLE: A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype (clinicaltrials.gov) - P3 | N=1719 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

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

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