▎WuXiEdited by Kant Content Team

AstraZeneca and Amgen recently announced that the full results of Tezspire (tezepelumab), jointly developed by the two companies, from the Phase 3 clinical trial WAYPOINT, have been published in The New England Journal of Medicine. Data shows,In patients with chronic rhinosinusitis with nasal polyps (CRSwNP), Tezspire significantly reduced the severity of nasal polyps, the need for subsequent surgery, and the use of systemic corticosteroids compared to placebo.

The trial met the co-primary endpoints, with Tezspire treatment significantly reducing nasal polyp score (NPS) and patient-reported nasal congestion score (NCS) at 52 weeks compared to placebo. The reduction in NPS was -2.065 (95% CI: -2.389, -1.742; p<0.0001), and the reduction in NCS was -1.028 (95% CI: -1.201, -0.855; p<0.0001). Notably,Improvement in NCS was observed as early as Week 2 of treatment and continued through Week 52.

All key secondary endpoints demonstrated statistically significant and clinically meaningful improvements. Notably,Tezspire reduced the need for subsequent nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% (p<0.0001) compared to placebo.

In CRSwNP patients, Tezspire was generally well-tolerated, with a safety profile consistent with its approved indication for severe asthma. In the WAYPOINT trial, the most commonly reported adverse events in the Tezspire group were COVID-19, nasopharyngitis, and upper respiratory tract infections. There were no clinically meaningful differences in safety outcomes between the two groups.

Tezspire is a “first-in-class” monoclonal antibody that exerts its therapeutic effects by inhibiting the action of thymic stromal lymphopoietin (TSLP).TSLP is a key cytokine positioned at the top of multiple inflammatory cascades, playing a crucial role in the initiation and persistence of allergic, eosinophilic, and other types of endothelial inflammation associated with severe asthma and other inflammatory diseases. Tezspire has been approved in the United States, the European Union, and nearly 60 countries/regions as an add-on maintenance treatment for adults and children aged 12 years and older with severe asthma. In addition to CRSwNP, Tezspire is also being developed for other potential indications, including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).

CRSwNP is a complex inflammatory disease characterized by persistent inflammation of the nasal mucosa accompanied by benign nasal polyp growth. Nasal polyps can block the nasal cavity, leading to breathing difficulties, olfactory disorders, runny nose, facial pain, sleep disturbances, and other adverse effects on quality of life. Epithelial dysfunction and inflammation are key features of chronic sinusitis, impairing the epithelium's ability to act as a physical and immune barrier against the external environment.

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