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Pulmonology news in October 2026 was defined largely by the American College of Chest Physicians (CHEST) 2026 Annual Meeting, held October 18-21 in Phoenix, Arizona, which supplied much of the month's clinical data. The month's most consequential regulatory story arrived October 30, when the US Food and Drug Administration (FDA) granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd; Inovio) to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP). It is the first plasmid DNA-based immunotherapy approved in the US.
In pulmonary vascular and interstitial lung disease, a risk-stratified analysis of the phase 3 ADVANCE OUTCOMES trial found that ralinepag reduced clinical worsening in pulmonary arterial hypertension, including among patients meeting low-risk criteria. A post hoc analysis of the phase 3 TETON-2 trial found fewer total progression events with inhaled treprostinil than placebo in idiopathic pulmonary fibrosis (126 vs 161; P =.003). In obstructive airway disease, tozorakimab improved patient-reported daily respiratory symptoms in the OBERON and TITANIA trials in COPD. An integrated SWIFT/AGILE analysis found that clinical remission with depemokimab at year 1 was associated with fewer asthma exacerbations in year 2. An ASPEN post hoc analysis linked patient-reported sputum color to neutrophil serine protease activity in bronchiectasis. HCPLive's on-site interviews also covered nalbuphine extended-release for IPF cough, AD109 in obstructive sleep apnea, and robotic bronchoscopy.
Check out this October 2026 pulmonology month in review for full coverage of these stories and more.
Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd; Inovio) is a plasmid DNA-based immunotherapy that delivers 1 plasmid encoding HPV-6 and HPV-11 antigens and a second encoding interleukin-12. It is given intramuscularly with the CELLECTRA 5PSP electroporation device over a 9-week regimen. The FDA granted accelerated approval October 30, 2026, to reduce the frequency of surgical papilloma excisions in adults with RRP, based on the RRP-001 trial, in which 27% (7/26; 95% CI, 12%–48%) of patients with 3 or more surgeries in the prior 12 months had a complete response through 12 months of follow-up. RRP-001 had no control arm, and Inovio plans to submit a draft confirmatory trial protocol to the FDA by the end of 2026.
The CHEST 2026 Annual Meeting brought new data across interstitial lung disease, COPD, severe asthma, sleep medicine, and interventional pulmonology, including 3 late-breaking abstracts. In this edition of the HCPLive Five, investigators discuss nalbuphine extended-release for IPF cough, tozorakimab in COPD, depemokimab remission, AD109 in obstructive sleep apnea, and robotic bronchoscopy.
Ralinepag, an investigational once-daily oral prostacyclin receptor agonist, reduced the risk of clinical worsening by 55% vs placebo in the phase 3 ADVANCE OUTCOMES trial (HR, 0.45; 95% CI, 0.33–0.62; P <.0001). A CHEST 2026 subgroup analysis stratified participants by 3 noninvasive low-risk criteria: NT-proBNP below 300 pg/mL, 6-minute walk distance above 440 m, and WHO functional class I or II. Jean Elwing, MD, of the University of Cincinnati College of Medicine, said patients who met all 3 criteria still had fewer clinical worsening events with ralinepag. Those who met none had an HR of 0.60 with a confidence interval crossing 1.0. The FDA has accepted the new drug application with a PDUFA date of June 24, 2027.
In SWIFT-1/-2, 29% of patients with type 2 asthma receiving twice-yearly depemokimab (Exdensur; GSK) achieved 4-component clinical remission at week 52, vs 23% with placebo. An integrated SWIFT/AGILE analysis presented at CHEST 2026 by Michael Wechsler, MD, found that 59% of patients in remission at year 1 remained in remission at year 2. Year 2 annualized exacerbation rates were 0.19 (95% CI, 0.12–0.29) among patients in remission at year 1 vs 0.69 (95% CI, 0.57–0.82) among those not in remission. Patients in remission at year 1 also showed greater improvement across all 3 secondary outcomes at year 2. The analysis is observational and shows association, not causation.
Tozorakimab (AstraZeneca), an anti–IL-33 monoclonal antibody, 300 mg every 4 weeks improved Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total scores vs placebo at week 52 in both phase 3 OBERON and TITANIA trials. Improvements spanned the breathlessness, cough/sputum, and chest symptom domains, according to an analysis presented at CHEST 2026. Frank Sciurba, MD, of the University of Pittsburgh, said symptom benefit matters to patients independent of exacerbation risk reduction. In the primary population of former smokers, the trials previously showed 29% and 34% reductions in moderate and severe exacerbations, respectively. The FDA has accepted the biologics license application for COPD under Priority Review, with a PDUFA date anticipated in the first quarter of 2027.
A post hoc analysis of the phase 3 ASPEN trial, presented at CHEST 2026, found that patient-reported sputum color reflected neutrophil serine protease activity and overall disease activity in bronchiectasis. Participants rated sputum color daily on a 6-point scale in the Bronchiectasis Exacerbation and Symptom Tool diary. Greater baseline purulence was associated with higher sputum neutrophil counts, Pseudomonas aeruginosa positivity, exacerbation rates, and Bronchiectasis-Computed Tomography scores, as well as lower postbronchodilator percent predicted forced expiratory volume in 1 second. Brensocatib (Brinsupri) reduced neutrophil elastase activity across all sputum color categories. James Chalmers, MBChB, PhD, of the University of Oxford, said patients with mucoid sputum can still be inflamed and benefit, which is relevant to growing interest in treating earlier disease.
A post hoc analysis of the phase 3 TETON-2 trial, presented at CHEST 2026, counted every disease progression event across 52 weeks instead of only the first. In total, 126 events occurred in 82 patients receiving inhaled treprostinil (Tyvaso; United Therapeutics) vs 161 events in 115 patients receiving placebo (P =.003). The difference was driven mainly by relative declines of 10% or more in percent predicted forced vital capacity (54 vs 86 events) and concurrent IPF exacerbation with respiratory hospitalization (6 vs 18 events). Adjudicated respiratory hospitalizations were numerically more frequent with inhaled treprostinil (45 vs 34 events), and the number of patients with more than 1 event did not differ significantly (26 vs 36; P =.166). Steven D. Nathan, MD, of Inova and the University of Virginia, said the findings support continuing therapy after a first progression event. Inhaled treprostinil remains investigational for IPF, with FDA review of the supplemental new drug application expected to be complete in late April 2027.