Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva, Theravance Biopharma, Royalty - LARVOL DELTA

GSK delivers continued strong performance (GSK Press Release) - "Total Q2 2025 sales £8.0 billion +1% AER; +6% CER Specialty Medicines sales £3.3 billion (+15%); Respiratory, Immunology & Inflammation £1.0 billion (+10%); Oncology £0.5 billion (+42%); HIV sales £1.9 billion (+12%) Vaccines sales £2.1 billion (+9%); Shingrix £0.9 billion (+6%); Meningitis vaccines £0.4 billion (+22%); and Arexvy £0.1 billion (+13%) General Medicines sales £2.6 billion (-6%); Trelegy £0.8 billion (+4%) Total operating profit +33% and Total EPS +35% driven by lower CCL charges partly offset by intangible asset impairments Core operating profit +12% and Core EPS +15% reflecting Specialty Medicines and Vaccines growth, higher royalty income and disciplined increased investment in R&D portfolio progression in Oncology and Vaccines"

Commercial • Chronic Obstructive Pulmonary Disease • Respiratory Syncytial Virus Infections

Real-world effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol in Chinese patients with symptomatic chronic obstructive pulmonary disease (COPD): a post-marketing, prospective, multicenter, observational study. (PubMed, Curr Med Res Opin) - "During the treatment, 10 (2.2%) participants reported FF/UMEC/VI-related adverse events. In real-world clinical practice in China, FF/UMEC/VI effectively improved symptoms and lung function in patients with symptomatic COPD and was well-tolerated."

Journal • Observational data • P4 data • Real-world evidence • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Reduction of asthma exacerbations after escalation from BUD/FORM or FP/SAL to FF/UMEC/VI (ERS 2025) - No abstract available

Asthma • Immunology • Respiratory Diseases

Single-inhaler triple therapy (FF/UMEC/VI) vs FF/VI in Chinese uncontrolled asthma adults (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Respiratory Diseases

Clinical remission and small airway improvements after one-year FF/UMEC/VI (ERS 2025) - No abstract available

Clinical • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Comparative in-vitro performance evaluation of two fluticasone furoate/ vilanterol/umeclidinium (100/25/62.5 mcg) multi-dose dry powder inhalers (ERS 2025) - No abstract available

Preclinical • Respiratory Diseases

Clinically Important Improvements and Disease Stability with Fluticasone Furoate/Umeclidinium/Vilanterol Once-Daily Single-Inhaler Triple Therapy in the ELLITHE Trial: A Post Hoc Responder Analysis. (PubMed, Pulm Ther) - "Despite overlapping responses to single and composite outcomes with odSITT, individual patterns support a multidimensional approach to evaluate benefits in COPD. Responders had higher baseline CAT scores and frequency of prior dual therapies. Short-term responses of FEV1 and/or CAT were reasonable predictors of long-term responses, including DS. DS was achievable for the majority of patients and may represent a useful outcome for future COPD research and management."

Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison of the Risk of Pneumonia Between Fluticasone Furoate/Umeclidinium/Vilanterol and Multiple-Inhaler Triple Therapy in Patients with COPD Using Health Insurance Claims Data: Final Analysis of Post-Marketing Database Surveillance in Japan. (PubMed, J Clin Med) - " There was no difference in the risk of CAP between patients treated with FF/UMEC/VI and MITT. This safety information may help healthcare providers select appropriate treatments."

Journal • P4 data • Reimbursement • US reimbursement • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Comparative Effectiveness of FF/UMEC/VI and BUD/GLY/FORM in Patients with COPD Stepping Up From Dual Therapy. (PubMed, Adv Ther) - "In this real-world study, SITT with FF/UMEC/VI was associated with a significantly lower rate and risk of exacerbations compared with BUD/GLY/FORM in patients stepping up from dual therapy."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

In Silico Lung Deposition Profiles of Three Single-Inhaler Triple Therapies in Patients with COPD Using Functional Respiratory Imaging. (PubMed, Int J Chron Obstruct Pulmon Dis) - "The first part evaluated budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) pressurized metered-dose inhaler (pMDI), beclomethasone dipropionate/glycopyrronium/formoterol fumarate dihydrate (BDP/G/F) pMDI, and fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) dry powder inhaler (DPI) at 30 L/min...These findings provide quantitative insights into relative lung deposition distribution profiles and efficiency of delivery for 3 inhaler options. Further research is needed to understand if these deposition patterns could translate into real-world clinical effectiveness differences."

Clinical • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Cost-Effectiveness of Single-Inhaler Versus Multiple-Inhaler Triple Therapy in COPD: A German Healthcare Perspective. (PubMed, Int J Chron Obstruct Pulmon Dis) - "These findings remained consistent across one-way sensitivity, scenario, and probabilistic analyses, highlighting the robustness of FF/UMEC/VI as a cost-effective solution for COPD management in Germany. FF/UMEC/VI offers clinical benefits and cost savings compared with non-ELLIPTA MITT, suggesting that it may reduce the burden of COPD in Germany and warranting consideration as a preferred treatment option by physicians."

HEOR • Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Use of fluticasone/umeclidinium/vilanterol in France: A population based study (PubMed, Rev Mal Respir) - "Our results demonstrate that triple inhaled therapy with FF/UMEC/VI is used in accordance with its marketing authorization in France in the vast majority of cases."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Effect of Preoperative Single-Inhaler Triple Therapy on Pulmonary Function in Lung Cancer Patients with Chronic Obstructive Pulmonary Disease and FEV1 < 1.5 L. (PubMed, Cancers (Basel)) - "Background/objectives: This study aimed to investigate the impact of single-inhaler triple therapy on selecting treatment for lung cancer and the perioperative period in lung cancer patients with chronic obstructive pulmonary disease (COPD) and a forced expiratory volume in 1 s (FEV1) <1.5 L. All patients had baseline FEV1 < 1.5 L. The therapeutic drug for COPD, fluticasone furoate/umeclidinium/vilanterol, was initiated 2 weeks preoperatively and continued until 3 months postoperatively... Preoperative triple therapy in lung cancer patients with untreated COPD and FEV1 < 1.5 L improved respiratory function and increased the feasibility of performing radical resection surgery. Furthermore, it was considered safe and effective, indicating the potential to maintain preoperative respiratory function without increasing perioperative complications."

Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Lung Cancer • Oncology • Palliative care • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor

Theravance Biopharma, Inc. Sells Remaining Royalty Interest in Trelegy Ellipta to GSK for $225 Million (PRNewswire) - "Theravance Biopharma, Inc...announced that it has entered into a definitive agreement to sell its remaining royalty interest in net sales of Trelegy Ellipta ('Trelegy') to GSK (NYSE: GSK) for $225 million in cash....Theravance Biopharma retains rights to up to $150 million in milestones from Royalty Pharma on Trelegy Ellipta net sales in 2025 and 2026, requiring minimal to no growth over 2024 actuals to be achieved; $225 million from royalty transaction announced today, in addition to the $1.1 billion upfront received in 2022, and up to $200 million in milestones (of which $50 million was received in 2025), brings total potential lifetime value from Trelegy Ellipta monetization efforts to $1.525 billion."

Commercial • Chronic Obstructive Pulmonary Disease

Trelegy Ellipta: Patents delisted for Trelegy Ellipta from Orange Book (Orange Book) - Patent no.s 8511304, 8511304*PED, 9333310, 9333310*PED, 8161968, 8161968*PED

Patent • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Trelegy Ellipta: Newly added patents in Orange Book (Orange Book) - Expiry on Jun 14, 2027, Oct 2, 2027, Feb 5, 2028

Patent • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Effect of Chronic Mucus Hypersecretion on Patients With COPD Achieving and Maintaining Disease Stability With Fluticasone Furoate/Umeclidinium/Vilanterol Versus Budesonide/Formoterol: A FULFIL Post Hoc Analysis (ATS 2025) - P3 | "Based on the SGRQ- and CAT-containing definitions used, twice as many patients receiving FF/UMEC/VI achieved disease stability up to Week 24 compared with BUD/FOR, irrespective of CMH status. Furthermore, patients maintained disease stability for longer with FF/UMEC/VI versus BUD/FOR, regardless of CMH status. These findings support the implementation of disease stability as a treatment target for optimizing patient management in COPD."

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Cough • Immunology • Respiratory Diseases

Unraveling Bronchiolitis Obliterans in Rheumatoid Arthritis (ATS 2025) - "Prior rheumatologic treatments included prednisone, hydroxychloroquine, and methotrexate. She is currently on mycophenolate mofetil and fluticasone furoate/ umeclidinium/ vilanterol inhaler.Earliest computed tomography (CT) scan of the chest in 2013 showed mild diffuse peribronchial wall thickening and mosaic attenuation...Ultimately radiographic pattern of her lung disease was thought to be OB secondary RA; she was started on inhaled fluticasone propionate and azithromycin, with plan for addition of rituximab.DiscussionDiagnosis of OB is complicated by comorbid conditions with overlapping presentations and the varied pulmonary involvement within RA...Optimal treatment of OB is unclear and disease course is often refractory to therapy with poor prognosis. Management includes a combination of inhaled bronchodilator therapy, macrolides, and aggressive immunomodulatory therapy."

Asthma • Cardiovascular • Fibrosis • Immunology • Inflammatory Arthritis • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • Sjogren's Syndrome

Exacerbation Reduction in Patients With Asthma Following Initiation of Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in the United States (ATS 2025) - "Significant reductions in asthma-related exacerbations, as well as lower OCS and SABA use, and reductions in asthma-related ED visits and medical costs were associated with the post-initiation period of FF/UMEC/VI treatment compared with the pre-initiation period. This provides novel, real-world evidence of the benefits of escalation to FF/UMEC/VI from ICS/LABA therapy in patients with asthma in the US, helping to inform treatment decisions in real-world clinical practice."

Clinical • Asthma • Immunology • Respiratory Diseases

Impact of Simultaneous Step-Up to High-Dose Fluticasone Furoate and Addition of Umeclidinium on a Clinical Remission Endpoint in Asthma: CAPTAIN Post Hoc Analysis (ATS 2025) - P3 | "This abstract is funded by: GSK (205715/NCT02924688) Rationale: Clinical remission (CR) is an ambitious and achievable treatment goal in asthma. Both increasing FF dose and adding UMEC contributed to improving clinical outcomes in patients with asthma. These results suggest that the greater odds of meeting the CR endpoint with FF/UMEC/VI 200/62.5/25 versus FF/VI 100/25 were mostly driven by the addition of UMEC. Although data over 52 weeks are needed to confirm achievement of CR, patients not yet considered for biologics with moderate-to-severe asthma uncontrolled on FF/VI 100/25 may gain greater benefits with simultaneous step-up to high-dose triple therapy versus increasing FF dose or adding UMEC alone."

Clinical • Retrospective data • Asthma • Immunology • Respiratory Diseases

Impact of Fluticasone Furoate/Umeclidinium/Vilanterol Inhaled Therapy on a Clinical Remission Endpoint in Asthma for Patients with Type 2 Inflammation: CAPTAIN Post Hoc Analysis (ATS 2025) - P3 | "Increasing FF dose and adding UMEC improved clinical outcomes for patients. More patients met the CR endpoint when adding UMEC, a long-acting muscarinic antagonist (LAMA), to FF/VI versus dual therapy alone, irrespective of T2 inflammation status at baseline in a symptomatic population not yet considered for biologics. Increasing FF dose also led to greater attainability of the CR endpoint, particularly in the patient subgroup with high T2 inflammation."

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

Establishing Outcomes of Once-daily Triple Therapy Plus as Needed Albuterol in Hospitalized Patients With COPD Exacerbations: The SUNDIAL-COPD Study (ATS 2025) - P4 | "Patients received Trelegy Ellipta 100/62.5/25 mcg as their primary inhaler within 24 hours of admission in combination with PRN albuterol...J Manag Care Spec Pharm, 2022. 28(12): p. 1366-1377."

Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Retrospective Analysis of Patient Profiles and Disease Burden for Patients With Chronic Obstructive Pulmonary Disease Who Initiated Triple Therapy in China (ATS 2025) - "Among patients in the SITT subgroup, 508 received FF/UMEC/VI and 3781 received BUD/GLY/FOR...CONCLUSIONS This study found that patients with COPD who were prescribed TT in China had a median age of 66 years and 64.8% were male. The most common comorbidities at baseline were hypertension and asthma, and more than half of patients with reported EOS had EOS >100 cells/μL."

Retrospective data • Asthma • Cardiovascular • Chronic Obstructive Pulmonary Disease • Hypertension • Immunology • Pulmonary Disease • Respiratory Diseases

Comparison of Individual and Composite Measures to Assess Disease Stability over Time in Patients with COPD Treated with Fluticasone Furoate/Umeclidinium/Vilanterol: A Post Hoc Analysis (ATS 2025) - P3 | "Disease stability can be assessed using individual components or a combination. A greater proportion of patients receiving FF/UMEC/VI achieved disease stability versus dual therapies, across the individual component and composite definitions used, using either CAT score stability measurements. Disease stability can be considered for individual components or combining components into a two- or three-component composite."

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Assessment of Disease Stability in Patients With COPD Receiving Single-inhaler Therapy With Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI and UMEC/VI: Post Hoc Analysis of the IMPACT Trial (ATS 2025) - P3 | "According to the definitions of disease stability used, a greater proportion of patients receiving FF/UMEC/VI achieved disease stability at Week 52, versus FF/VI or UMEC/VI. Patients receiving FF/UMEC/VI also maintained disease stability for longer, versus FF/VI or UMEC/VI. These findings provide further support for disease stability as a practical treatment target for patients with COPD, with further evidence needed to define optimum thresholds for each component."

Clinical • Retrospective data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases