AstraZeneca and Amgen announced positive top-line results from the Phase III WAYPOINT trial, revealing that Tezspire (tezepelumab) achieved statistically significant and clinically meaningful reductions in nasal polyp size and nasal congestion compared to placebo in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The WAYPOINT trial is a randomized, double-blind study evaluating the efficacy and safety of subcutaneous Tezspire in adult patients with severe CRSwNP who remained symptomatic despite treatment with standard-of-care intranasal corticosteroids (INCS).
Clinical Impact and Expert Commentary
"Chronic rhinosinusitis with nasal polyps negatively impact patients’ daily lives with obstructions leading to disturbances in smell, taste and sleep as well as pain and fatigue," said Dr. Joseph Han, Vice Chair of Rhinology & Endoscopic Sinus and Skull Base Surgery, and Allergy, Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, US, and co-primary investigator in the trial. "The impressive data from the WAYPOINT trial demonstrate tezepelumab’s potential as a new treatment for patients whose lives are disrupted by this debilitating disease."
Dr. Brian Lipworth, Professor of Allergy and Pulmonology, Scottish Centre for Respiratory Research, and Tayside Rhinology Ear, Nose and Throat Clinic, Ninewells Hospital University of Dundee in Scotland, UK, and co-primary investigator in the trial, added, "Patients diagnosed with nasal polyps continue to experience significant burden including repeat surgeries and frequent treatment with high doses of oral corticosteroids, which are associated with serious systemic side effects. The tezepelumab data are clinically meaningful and offer patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems."
WAYPOINT Trial Details
The WAYPOINT trial enrolled adult participants with severe CRSwNP who were symptomatic despite receiving standard-of-care treatment with intranasal corticosteroids. The primary endpoints of the trial focused on the change in nasal polyp size and the reduction in nasal congestion. The trial's design involved subcutaneous administration of Tezspire compared to placebo.
Mechanism of Action and Broader Implications
Sharon Barr, Executive Vice President, AstraZeneca BioPharmaceuticals R&D, stated, "We are excited by the positive results from the Phase III WAYPOINT trial, which show that patients with nasal polyps strongly benefitted from treatment with tezepelumab. These results reinforce that tezepelumab’s first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases."
The safety and tolerability profile of Tezspire in the WAYPOINT trial were consistent with the established safety profile of the drug. Full results from the WAYPOINT trial will be presented to regulatory authorities and at a future medical meeting.
Tezspire's Existing Approvals and Commercialization
Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 countries. It is available as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.
Collaboration between Amgen and AstraZeneca
Amgen and AstraZeneca collaborate on Tezspire, sharing costs and profits equally, with AstraZeneca leading development and Amgen leading manufacturing. In North America, Amgen records product sales in the US, while AstraZeneca records its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca records product sales, and Amgen records profit share as Other/Collaboration revenue.
