New data presented at ATS 2024 show the potential of Tezspire (tezepelumab-ekko) to help patients living with COPD

The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant (90% CI: -6, 36; p[1-sided]=0.1042). The results will be featured in presentations at the American Thoracic Society (ATS) International Conference, May 17-22, in San Diego.

Importantly, this proof-of-concept study showed that, in patients with BEC greater than 150 cells/µL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo. Studies suggest that approximately 65% of bio-eligible patients with COPD have a BEC greater than 150 cells/L. Among patients with BEC greater than 300 cells/µL, tezepelumab led to a numerical reduction of 46% in the rate of moderate or severe exacerbations .Trends towards improved outcomes were also seen with tezepelumab use for pre-bronchodilator FEV1 and SGRQ total score.

"Despite advances in treatments for patients with COPD, there is still a pressing need for effective therapies that can improve their clinical outcome, especially for those with eosinophil counts above 150 cells/µL," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "We are now actively planning a Phase III clinical program evaluating tezepelumab in patients with COPD."

A subgroup analysis of the COURSE trial also showed treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1) (improvement of 63 mL and 146 mL in BEC greater than 150 and greater than 300 cells/L respectively, compared to placebo) and in quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC greater than 150 and greater than 300 cells/L respectively).

The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported ( greater than 10%) adverse events for tezepelumab were worsening of COPD (12.1%) and incidents of COVID-19 infections (14.5%) (this trial commenced in July 2019).

"I believe biologics will play a critical role in the future care of COPD, and trials such as the tezepelumab COURSE trial are central to understanding and shaping the treatment landscape," said Dr. Dave Singh, professor of respiratory pharmacology at the University of Manchester and lead investigator on the trial. "The tezepelumab COURSE results are particularly important as they show activity in COPD across a broad patient population including those with baseline blood eosinophil counts greater than 150 cells/L."

About the COURSE Phase IIa Trial: COURSE was a Phase IIa multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe COPD receiving triple inhaled maintenance therapy, and having had two or more documented COPD exacerbations in the 12 months prior to Visit 1. A total of 337 patients were randomized globally, with patients stratified by region and prior number of exacerbations (two vs. three or more). Patients received tezepelumab 420 mg or placebo administered via subcutaneous injection at the trial site every four weeks over a 52-week treatment period. The trial included a post-treatment follow-up period of 12 weeks.