Tezepelumab for COPD Moves into Phase 3 Planning

Tezepelumab showed promise in a phase 2a proof-of-concept trial investigating the drug’s efficacy in treating moderate to very severe chronic obstructive pulmonary disease (COPD), according to a news release from codevelopers Amgen and AstraZeneca.¹

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Overall, when compared with placebo, the thymic stromal lymphopoietin (TSLP) inhibitor numerically reduced the annualized rate of COPD exacerbations in individuals with moderate to very severe COPD by 17% (90% CI, −6 to 36; P = .104), according to the release.¹ Importantly, reductions were more prevalent among study participants in a prespecified subgroup with baseline eosinophil count (BEC) equal to or greater than 150 cells/µL (37%; 95% CI, 7 to 57).¹

Investigators also observed a greater trend in reduction of disease exacerbations in the small number of trial participants with BEC equal to/greater than 300 cells/µL, said Amgen. These topline data support the company’s planning for phase 3 development of tezepelumab for COPD.¹

The phase 2a COURSE trial evaluated tezepelumab efficacy in participants with a broad range of EOS levels and regardless of inflammatory drivers, emphysema, chronic bronchitis, and smoking status. No participants were excluded based on individual baseline BEC, according to the release.¹

Amgen announced that the COURSE trial results have been accepted for presentation during the Clinical Trials Symposium at the American Thoracic Society 2024 International Conference, May 17-22, 2024, in San Diego, CA.¹

The tezepelumab news may increase the potential for approval of a second biologic agent for treatment of COPD after the announcement in February by Sanofi and Regeneron of the US Food and Drug Administration’s (FDA) acceptance of a supplemental biologics license application for dupilumab as add-on maintenance therapy in adults with uncontrolled COPD. A PUDFA date was set then for June 27, 2024.²

"We are excited by these data and optimistic about the potential tezepelumab has for patients with COPD, a condition that continues to have a significant unmet medical need," James Bradner, MD, executive vice president of Research and Development and chief scientific officer at Amgen, said in the news release.¹

“We look forward to presenting the full data set at the congress and based on these findings, we are actively planning for the Phase 3 development of tezepelumab in COPD.”¹

Tezepelumab is indicated in the US as add-on maintenance treatment for severe asthma in adult and pediatric patients aged 12 years and older.³ With the approval by the US FDA December 2021 tezepelumab became the first biologic agent found to both consistently and significantly reduce exacerbations of asthma in a broad population of individuals with severe asthma and with no labeled limitations based on asthma phenotype or key biomarkers (ie, BEC, allergic status, and fractional exhaled nitric oxide). The company’s biologics license application was granted FDA priority review.³

References

1. Amgen to present Tezspire phase 2a COPD data at ATS 2024. News release. Amgen. April 16, 2024. Accessed April 17, 2024. https://www.amgen.com/newsroom/press-releases/2024/04/amgen-to-present-tezspire-phase-2a-copd-data-at-ats-2024
2. Halsey G. FDA accepts dupilumab sBLA for priority review for treatment of COPD with type 2 inflammation. Patient Care. February 23, 2024. Accessed April 17, 2024. https://www.patientcareonline.com/view/fda-accepts-dupilumab-sbla-for-priority-review-for-treatment-of-copd-with-type-2-inflammation
3. Tezspire (tezepelumab) approved in the US for severe asthma. News release. AstraZeneca. December 17, 2021. Accessed April 17, 2024. https://www.astrazeneca.com/media-centre/press-releases/2021/tezspire-tezepelumab-approved-in-the-us-for-severe-asthma.html#