Full results from the positive Phase III WAYPOINT trial showed AstraZeneca and Amgen's Tezspire (tezepelumab) significantly reduced nasal polyp severity, the need for subsequent surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.
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These data were published in the New England Journal of Medicine and presented as a late-breaking oral presentation at the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organisation (WAO) Joint Congress in San Diego, CA.
Treatment with Tezspire significantly reduced nasal polyp severity measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.065 (95% CI: -2.389, -1.742; p<0.0001) and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 (95% CI: -1.201, -0.855; p<0.0001) at week 52 compared to placebo. Improvements in NPS were observed as early as week four and NCS as early as week two (the first post-treatment assessment respectively) and were sustained through week 52.
Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population. Importantly, Tezspire significantly 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.
Dr Joseph Han, vice chair of department of otolaryngology - head and neck surgery, Old Dominion University, US, and co-primary investigator in the trial, said: “Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids. The WAYPOINT results are clinically meaningful and suggest that tezepelumab could greatly reduce the burden of nasal polyps for patients by nearly eliminating the need for future surgery and corticosteroid use and by significantly reducing nasal polyp size and congestion.”
Sharon Barr, executive vice president, biopharmaceuticals R&D said: “The WAYPOINT results demonstrate the potential for Tezspire to provide a much-needed option for patients with chronic rhinosinusitis with nasal polyps. With its first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, the data add to the body of evidence that tezepelumab can transform care for patients with epithelial-driven inflammatory diseases.”