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

From disease improvement to disease stability in patients with COPD: IMPACT post hoc analysis (ERS 2025) - P3 | "In this high-risk IMPACT population, patients receiving FF/UMEC/VI were more likely to achieve the composite endpoint vs dual therapy. Funding GSK (CTT116855/NCT02164513)."

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

Time -to - understand treatment response (ERS 2025) - P3 | "In both comparisons, total event rates continued to diverge throughout follow-up, despite loss of response on first events. T was early (34 days) for UMEC/VI vs. FF/UMEC/VI, with higher eosinophils in T-1 UMEC/VI than in T+1 UMEC/VI or T-1 triple therapy."

Respiratory Diseases

Investigating individual effects of ICS on COPD exacerbations with causal machine learning (ERS 2025) - P3 | "We focused on two treatment comparisons: fluticasone furoate/umeclidinium/vilanterol (FF/U/V, ICS/LAMA/LABA) versus U/V, and FF/V versus U/V... Causal ML models trained for related exacerbation outcomes selected similar, yet also slightly different patient profiles as best responders for FF. Combining models may result in a more complete understanding of individual response."

Clinical • Machine learning • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Reduction of asthma exacerbations after escalation from BUD/FORM or FP/SAL to FF/UMEC/VI (ERS 2025) - "Conclusions Patients who escalate to FF/UMEC/VI from ICS/LABA significantly reduced asthma exacerbations irrespective of prior BUD/FORM or FP/SAL treatment. Funding GSK (300181)."

Asthma • Immunology • Respiratory Diseases

Single-inhaler triple therapy (FF/UMEC/VI) vs FF/VI in Chinese uncontrolled asthma adults (ERS 2025) - P3 | "FF/UMEC/VI 100 µg can further improve lung function vs FF/VI 100 µg, with a small improvement in ACQ-7, in Chinese asthma pts; but this was not observed with FF/UMEC/VI vs FF/VI 200 µg."

Clinical • Asthma • Immunology • Respiratory Diseases

Clinical remission and small airway improvements after one-year FF/UMEC/VI (ERS 2025) - "1-year FF/UMEC/VI (200/62.5/25µg) resulted in improved airway mucus, LA, TAC and VDP and 4- domain clinical remission in 7/15 evaluated participants."

Clinical • Asthma • Immunology • Respiratory Diseases

TETRIS: A 24-month, prospective study to observe clinical outcomes in COPD patients with different treatment journeys in Germany (ERS 2025) - "COPD patients on continuous therapy with FF/UMEC/VI appear to benefit the most in terms of clinical outcomes. Funding GSK (214468)"

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

On the disposition of airway mucus-plugs in asthma before and after treatment (ERS 2025) - "Treatment of asthma with either anti-IL-5Rα and FF/UMEC/VI significantly reduced mucus burden similar to healthy volunteers. These results support the notion that airway mucus may serve as a treatable trait in asthma."

Asthma • Immunology • Inflammation • 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) - "The delivered dose, FPD, MMAD and GSD of fluticasone furoate, vilanterol and umeclidinium delivered by the two devices were similar at specified flow rates, suggesting similar drug delivery into the lungs under ideal conditions using correct inhaler technique."

Preclinical • Respiratory Diseases

From Varices to Viral Infiltrate: Diagnosing CMV Gastritis in a Cirrhotic, Immunocompromised Host (ACG 2025) - "We present a case of biopsy-proven CMV gastritis in a patient with metabolic-associated steatohepatitis (MASH) cirrhosis and chronic B-cell depletion from long-term rituximab therapy.Case Description/ A 68-year-old woman with compensated MASH cirrhosis, morbid obesity, rheumatoid arthritis (on rituximab for 9 years), interstitial lung disease (on fluticasone furoate/umeclidinium/vilanterol), atrial fibrillation on anticoagulation, prediabetes, hypothyroidism, and depression underwent upper endoscopy for variceal screening...Concurrent plasma CMV DNA by NAAT was elevated at 5,530 IU/mL.Given her immunocompromised status, close coordination with the infectious disease team was undertaken, and the patient was initiated on intravenous ganciclovir therapy. This case highlights the importance of maintaining a broad differential diagnosis when evaluating gastric mucosal changes in immunosuppressed patients with cirrhosis...Histologic evaluation remains essential, especially in..."

Atrial Fibrillation • Cardiovascular • CNS Disorders • Cytomegalovirus Infection • Depression • Dermatology • Endocrine Disorders • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Hepatology • Immunology • Infectious Disease • Inflammatory Arthritis • Interstitial Lung Disease • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Portal Hypertension • Psychiatry • Pulmonary Disease • Respiratory Diseases • Rheumatoid Arthritis • Rheumatology • CD68

ETHA: Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma (clinicaltrials.gov) - P3 | N=31 | Active, not recruiting | Sponsor: Dr. Grace Parraga | Trial completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Economic Analysis of New Single-Inhaler Triple Therapies in Patients with COPD in the UK. (PubMed, Int J Chron Obstruct Pulmon Dis) - "At a willingness-to-pay threshold of £20,000 per QALY, the probability of FF/UMEC/VI being cost-effective was 99.9%, 100%, and 99.3% versus BUD320/GLY/FOR, BUD160/GLY/FOR, and BDP/FOR/GLY, respectively. Based on this analysis, FF/UMEC/VI is a dominant (improved outcomes with cost savings) treatment option compared with other SITTs for the treatment of patients with COPD in the UK."

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

Theravance Biopharma, Inc. Reports Second Quarter 2025 Financial Results and Provides Corporate Update (PRNewswire) - "GSK posted second quarter 2025 global net sales of approximately $1.1 billion (up 4% vs. the second quarter of 2024) and year-to-date net sales of approximately $2.0 billion (up 8% vs. 2024 year-to-date): Currently on track to exceed full year (FY) 2025 global net sales of ~$3.4 billion (representing minus 1% growth vs. 2024) required to trigger $50M milestone from Royalty Pharma."

Sales • Asthma • Chronic Obstructive Pulmonary Disease

ANTES B+ Clinical Trial (clinicaltrials.gov) - P4 | N=48 | Terminated | Sponsor: Fundacio Privada Mon Clinic Barcelona | N=1028 ➔ 48 | Trial completion date: Sep 2025 ➔ Jan 2025 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2025 ➔ Jan 2025; Delays in the opening and activation of participating sites, and a low recruitment rate, with only 48 participants enrolled over the course of one year

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

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

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