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Tezepelumab Lowers Nasal Polyp Severity in CRSwNP During Phase 3 WAYPOINT, with Joseph Han, MD
Tezepelumab significantly reduced nasal polyp severity in CRSwNP patients during the phase 3 WAYPOINT trial, lowering the need for surgery by 92%.
Tezepelumab reduced nasal polyp severity in patients with severe chronic rhinosinusitis during the phase 3 randomized WAYPOINT trial.1 These findings, presented at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego, suggest tezepelumab could help prevent the need for nasal polyp surgery for individuals with severe rhinosinusitis.
“We saw almost near complete elimination for the need for surgery in the treatment group,” investigator Joseph Han, MD, from Eastern Virginia Medical School, told HCPLive at the meeting.
The US Food and Drug Administration (FDA) approved tezepelumab for the self-administration of a pre-filled, single-use pen for severe asthma in February 2023.2 More recently, Han and colleagues conducted the phase 3 WAYPOINT trial to assess the efficacy and safety of tezepelumab, a human monoclonal antibody that blocks the activity of an upstream thymic stromal lymphopoietin, for the treatment of severe chronic rhinosinusitis with nasal polyps (CRSwNP).3
Adults were randomized 1:1 to tezepelumab 210 (n = 203) or placebo (n = 205) subcutaneously every 4 weeks for 52 weeks.1 Participants on tezepelumab had a signficantly improved total nasal polyp (least squares mean difference, 2.101; 95% confidence interval [CI], 2.414 – 1.788; P < .0001) and mean nasal congestion score (mean difference, 1.088; 95% CI, 1.261 – 0.915; P < .0001) compared with placebo. At week 52, tezepelumab also brought significant improvements in loss of smell, SNOT-22, Lund-Mackey score, and total symptom score (P < .0001).
In the trial, tezepelumab improved nasal congestion and sense of smell as early as week 2. The significant reduction in SNOT-22, which can help determine the need for rescue medication or treatment, resulted in a significant reduction in the use of systemic steroids.
Tezepelumab also reduced the need for nasal polyp surgery or systemic corticosteroid treatment by 92% compared with placebo (hazard ratio [HR], 0.08; 95% confidence interval [CI], 0.03 – 0.17). Only 1 patient in the treatment arm required surgery, compared with > 40 patients in the placebo arm.
“What's exciting is the phase 3 data for waypoint has so much information,” Han said. “The next immediate step is looking at a subgroup analysis of different endpoints and different study populations within [CRSwNP].”
References
Han, J, Lipworth, B, Desrosiers, M, et al. Efficacy And Safety Of Tezepelumab In Adults With Severe Chronic Rhinosinusitis With Nasal Polyps: Results From The Phase 3 WAYPOINT Study. J Allergy Clin Immunol. Late-breaker presented at the 2025 AAAAI annual meeting in San Diego from February 28 to March 3.
Iapoce, C. FDA Approves Tezepelumab Self-Administration for Severe Asthma. HCPLive. February 2, 2023. https://www.hcplive.com/view/fda-approves-tezepelumab-self-administration-severe-asthma. Accessed February 21, 2025.
Derman, C. Tezepelumab Reduces Nasal Polyp Severity in Severe CRSwNP During Phase 3 Trial. HCPLive. February 22, 2025. https://www.hcplive.com/view/tezepelumab-reduces-nasal-polyp-severity-severe-crswnp-phase-3-trial. Accessed March 11, 2025.
