Significantly Reduced Nasal Congestion, Polyp Size and Nearly Eliminated Need for Surgery
Data Published in NEJM and Presented at AAAAI/WAO 2025
THOUSAND OAKS, Calif., March 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced full results from the Phase 3, registrational WAYPOINT trial demonstrating that TEZSPIRE® (tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) compared to placebo. The data were published today in the New England Journal of Medicine and were highlighted as a late-breaking oral presentation during the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego.
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 assessments, respectively) and were sustained through week 52.
"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," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "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."
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 nasal polyp surgery by 98% (p<0.0001) and the need for systemic corticosteroid treatment by 88% (p<0.0001) compared to placebo.
"Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids," 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, and co-primary investigator in the trial. "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."
Table 1: Summary of co-primary and key secondary efficacy endpoints
| Endpoint |
Tezepelumab (n=203) |
Placebo (n=205) |
Difference vs. Placebo (95% CI) |
| Total Nasal Polyp Score (range 0-8)* |
-2.458 (0.114) |
-0.392 (0.118) |
-2.065 (-2.389, -1.742); p<0.0001** |
| Nasal Congestion Score (range 0-3)* |
-1.743 (0.062) |
-0.715 (0.064) |
-1.028 (-1.201, -0.855); p<0.0001** |
In patients with CRSwNP, TEZSPIRE had a safety profile consistent with its approved severe asthma indication. The most frequently reported adverse events for TEZSPIRE in the WAYPOINT trial were COVID-19, nasopharyngitis, and upper respiratory tract infection.
TEZSPIRE® (tezepelumab-ekko) U.S. Indication
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
