Amgen, Inc. and AstraZeneca PLC still are working out the specifics of their Phase III program for Tezspire (tezepelumab) in chronic obstructive pulmonary disease (COPD), including whether enrollment will be limited to patients with specific eosinophil levels, but the companies believe newly presented Phase IIa results in COPD justify moving the anti-TSLP antibody into pivotal trials.
Key Takeaways
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Tezspire showed greater efficacy in a Phase IIa trial in COPD in patients with high eosinophil levels than in Phase III trials of Dupixent, with efficacy in a broad range of blood eosinophil counts (BEC).
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Dupixent will be the first biologic to market for COPD, but there is a large unmet need for the treatment of patients with frequent moderate to severe exacerbations
Results from the Phase IIa COURSE clinical trial in COPD were detailed on 19 and 20 May at the American Thoracic Society (ATS) International Conference in San Diego. Amgen and AstraZeneca previously reported that the trial did not achieve statistical significance on the primary endpoint of reduction in moderate-to-severe COPD exacerbations at 52 weeks, with a 17% reduction in the annual rate compared with placebo (p=0.1042)