Amgen and AstraZeneca have reported complete outcomes from the registrational Phase III WAYPOINT trial of Tezspire (tezepelumab-ekko) for treating chronic rhinosinusitis with nasal polyps (CRSwNP).
The trial showed that treatment with the therapy decreased the severity of nasal polyps and congestion at week 52, as well as the need for surgery and the use of systemic corticosteroid.
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Severity of nasal polyps and congestion were measured using the measurements of co-primary endpoints, Nasal Polyp Score (NPS), and participant-reported Nasal Congestion Score (NCS).
The results highlight the therapy’s impact on reducing the need for nasal polyp surgery by 98% and systemic corticosteroid treatment by 88% against placebo.
They reflect Tezspire’s mechanism of action, which targets the primary source of inflammation at the airway epithelium.
Amgen research and development executive vice-president Jay Bradner said: “Chronic rhinosinusitis with nasal polyps is a recurrent condition often requiring repeat courses of systemic corticosteroids, even for patients on currently available biologics, and can require repeat surgeries.
“The WAYPOINT data highlight the potential of targeting inflammation at the epithelium to provide lasting relief for those with CRSwNP, adding to the efficacy profile that has been well established for Tezspire in severe asthma.”
Developed jointly by AstraZeneca and Amgen, tezepelumab is a human monoclonal antibody that inhibits thymic stromal lymphopoietin (TSLP) activity.
The companies updated their partnership agreement in 2020, with AstraZeneca overseeing the drug’s general development and Amgen leading manufacturing, sharing expenses and profits equally.
Governance of the partnership is overseen by joint bodies, with Amgen recognising sales of Tezspire in the US and AstraZeneca in Canada.
AstraZeneca also leads commercialisation outside North America.
AstraZeneca recently reported positive outcomes from a planned interim analysis of a Phase III trial of camizestrant with a cyclin-dependent kinase (CDK) 4/6 inhibitor for treating hormone receptor (HR) positive, HER2-negative advanced breast cancer.
