Q1 2026 Recap: Pulmonology News and Updates

Pulmonology opened Q1 2026 with long-overdue clinical infrastructure and closed it with one of the most consequential chronic obstructive pulmonary disease (COPD) trial readouts in years. January brought CHEST's first guideline dedicated to biologic selection and sequencing in severe asthma — a practical framework for a therapeutic landscape that has grown faster than the evidence guiding its use — alongside FDA clearance of LEADOPTIK's LIA system, a biopsy tool that embeds real-time depth imaging into the needle itself and may meaningfully compress the diagnostic timeline in lung cancer. February's signal came from the pipeline: verekitug's phase 2 VALIANT data positioned the TSLP receptor antagonist as a credible addition to the severe asthma biologic class, and real-world findings for AREXVY extended the case for RSV vaccination in older adults by linking it to reductions in major adverse cardiovascular events during RSV-related hospitalizations.

March was defined by COPD. Tozorakimab's dual phase 3 success in OBERON and TITANIA — across all eosinophil levels and smoking histories — established IL-33 inhibition as a viable mechanism in a broad COPD population, not just the type 2–enriched subgroups that current approved biologics require. The month also delivered ENCORE, Insmed's confirmatory trial for Arikayce in antibiotic-naïve MAC lung disease, which posted a 30-percentage-point gap in 6-month culture conversion over multidrug therapy alone and set up a label expansion filing for the second half of 2026. Taken together, Q1 reflected a field pressing simultaneously on multiple fronts: earlier and more precise diagnosis, smarter biologic sequencing in asthma, and the steady extension of anti-inflammatory therapy into diseases — COPD, MAC lung disease — where its reach was, until recently, limited.

Check out this Q1 2026 pulmonology recap for a look at HCPLive's coverage of the top news and research from the first quarter of the year:

New CHEST Recommendations Guide Biologic Use for Severe Asthma

CHEST released its first guideline dedicated to choosing and sequencing biologics in severe asthma, offering 7 evidence-based recommendations that often favor dupilumab, especially for patients with frequent exacerbations or steroid dependence. The guideline fills a major gap for clinicians navigating biologic switches after treatment failure, helping tailor therapy based on biomarkers, comorbidities, and response patterns.

FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy

The FDA cleared LEADOPTIK's Last Inch Assessment system, a biopsy tool that embeds high-resolution depth imaging directly into the needle to confirm real-time tissue sampling, offering 50× higher resolution than current technologies. With preclinical data showing >95% biopsy accuracy, the system could significantly reduce diagnostic delays in lung cancer, the leading cause of cancer death, and strengthen early detection efforts that can cut mortality by up to 25%.

Phase 2 VALIANT: Verekitug Reduces Average Annual Asthma Flare-Ups

Topline results from the phase 2 VALIANT trial show that verekitug met its primary endpoint, demonstrating statistically significant reductions in annualized asthma exacerbation rate compared with placebo in adults with severe asthma. The TSLP receptor antagonist achieved a 56% exacerbation reduction at the 100 mg every-12-weeks dose, with Upstream Bio planning to advance the drug into phase 3 trials in severe asthma and chronic rhinosinusitis with nasal polyps.

AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV

New real-world data from GSK show that AREXVY was associated with 75.6% effectiveness against RSV-related hospitalization in adults aged 60 and older, with exploratory endpoints also demonstrating reductions in major adverse cardiovascular events, including heart attack and stroke, during RSV-related hospitalizations. The findings, presented at RSVVW'26 in Rome, were derived from a retrospective cohort study of more than 2.5 million US patients and a separate nationwide Danish cohort of adults with COPD.

IL-33 Inhibitor Tozorakimab Cuts COPD Exacerbations in Phase 3 Trials

Tozorakimab, an investigational monoclonal antibody targeting IL-33, met its primary endpoint in both the phase 3 OBERON and TITANIA trials, reducing moderate-to-severe COPD exacerbation rates compared with placebo in former smokers and in the overall population, which included current smokers across all eosinophil levels and lung function severity stages. The results, announced by AstraZeneca on March 27, position tozorakimab as the first IL-33–targeting biologic to demonstrate significant exacerbation reduction across 2 replicate confirmatory trials in a broad COPD population; specific rate ratios and P values were not disclosed in the high-level announcement. Full data are expected at an upcoming medical meeting, with 2 additional LUNA program trials — PROSPERO and MIRANDA — still ongoing.

ENCORE: ARIKAYCE Meets End Points, Improves Respiration in MAC Lung Disease

Insmed's phase 3b ENCORE trial of amikacin liposome inhalation suspension (Arikayce) plus guideline-based multidrug therapy met its primary endpoint and all multiplicity-controlled culture conversion endpoints in antibiotic-naïve patients with a new MAC lung infection, with culture conversion by month 6 achieved in 87.8% of treated patients versus 57.0% on placebo and durable conversion at month 15 in 76.2% versus 47.6%. The results fulfill an FDA post-marketing requirement associated with Arikayce's existing accelerated approval for refractory MAC lung disease, and Insmed plans to file a supplemental NDA in the second half of 2026 seeking both label expansion into the antibiotic-naïve population and conversion to traditional approval. The ENCORE population is meaningfully broader than the refractory indication that preceded it, and the 30-percentage-point gap in 6-month culture conversion underscores the magnitude of added benefit over multidrug therapy alone.