AstraZeneca and Amgen have announced positive results from the Phase 3 WAYPOINT trial evaluating Tezspire (tezepelumab) in adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). The trial assessed the efficacy and safety of subcutaneous Tezspire in patients symptomatic despite standard-of-care intranasal corticosteroids.
The WAYPOINT trial met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful reduction in nasal polyp size and nasal congestion compared to placebo. The safety and tolerability of Tezspire were consistent with its known profile.
CRSwNP is a chronic inflammatory disease of the nasal mucosa characterized by nasal polyps. Patients often experience breathing difficulties, reduced sense of smell, nasal discharge, facial pain, and sleep disturbance, significantly impacting their quality of life.
Brian Lipworth, Ninewells Hospital University of Dundee and co-primary investigator, noted, "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 [Tezspire] data is clinically meaningful and offers patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems."
Tezspire is designed to inhibit TSLP, a key player in allergic, eosinophilic, and other endothelial inflammation types associated with severe asthma and other inflammatory diseases. It is already approved in the US, EU, and nearly 60 countries as an add-on maintenance treatment for severe asthma in patients aged 12 years and older.
Sharon Barr, executive vice president, biopharmaceuticals research and development, AZ, stated, "These results reinforce that [Tezspire’s] mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases."
Full results from the WAYPOINT trial will be shared with regulatory authorities and presented at an upcoming medical meeting.
