Tezepelumab, a thymic stromal lymphopoietin (TSLP) inhibitor developed by AstraZeneca and Amgen, demonstrated significant reductions in chronic obstructive pulmonary disease (COPD) exacerbations among eosinophilic subgroups, regardless of chronic bronchitis status, according to new post hoc findings presented at the 2025 American Thoracic Society (ATS) International Conference. These results further support the potential for biomarker-driven biologic therapies in COPD, a historically underserved market, says GlobalData.
GlobalData’s latest analysis reveals that tezepelumab, evaluated in the Phase IIa COURSE trial, achieved a 26 per cent reduction in annualised moderate or severe exacerbations in patients with chronic bronchitis (CB), with a 28 per cent reduction in those with baseline blood eosinophil counts (BECs) ≥150 cells/μL. Notably, in patients without CB but with elevated BECs, a 56 per cent reduction was observed. These findings highlight the impact of type 2 inflammation and eosinophilic status in shaping treatment response.
Asiyah Nawab, Healthcare Analyst, GlobalData, comments, “These subgroup findings reinforce the growing momentum around precision medicine in COPD. While tezepelumab did not meet its primary endpoint in the overall trial population, the marked benefit in biomarker-defined groups could pave the way for future regulatory and commercial strategies centred on eosinophilic inflammation.”
The COURSE study enrolled 337 patients with moderate to very severe COPD and at least two exacerbations in the prior year, all of whom were on optimised triple inhaled therapy. Participants received either tezepelumab 420mg subcutaneously every four weeks or a placebo for 52 weeks. In addition to exacerbation reductions, tezepelumab was associated with improvements in lung function and quality of life, particularly in CB patients with elevated eosinophils.
These results align with prior patterns seen in other biologics targeting eosinophilic COPD, including GSK’s Nucala (mepolizumab) and AstraZeneca’s Fasenra (benralizumab). However, tezepelumab’s upstream mechanism of action may offer a broader anti-inflammatory effect, which could differentiate it in a competitive landscape increasingly defined by biomarker stratification.
Nawab continues: “Biologics remain a small segment of the COPD market, largely due to underwhelming results in unselected populations. Tezepelumab’s ability to deliver clinically meaningful outcomes in eosinophilic subgroups, if confirmed in Phase III trials, could establish it as a valuable add-on therapy for high-risk patients unresponsive to standard inhaled regimens.”
From a commercial standpoint, AstraZeneca’s existing respiratory portfolio, including Symbicort and Fasenra, may offer strategic leverage for market integration. However, Nawab notes that payers will require clear evidence of clinical value and biomarker-based stratification to justify premium pricing.
Nawab concludes: “Tezepelumab’s trajectory will depend on its ability to validate these subgroup effects in a pivotal program. In an increasingly crowded and cost-sensitive biologics space, a successful precision medicine strategy will be essential to achieving market access and uptake.”