Tezspire Meets Co-Primary Endpoints in Phase III WAYPOINT Trial for Chronic Rhinosinusitis with Nasal Polyps
Key Insights
Tezspire (tezepelumab) demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size compared to placebo in the Phase III WAYPOINT trial.
The WAYPOINT trial also showed that Tezspire significantly reduced nasal congestion in adult patients with severe chronic rhinosinusitis with nasal polyps (search) (CRSwNP).
The safety and tolerability profile of Tezspire in the WAYPOINT trial was consistent with its known profile, reinforcing its potential as a treatment option.
AstraZeneca and Amgen's Tezspire (tezepelumab) has shown positive results in the Phase III WAYPOINT trial for patients with chronic rhinosinusitis with nasal polyps (search) (CRSwNP). The trial demonstrated a statistically significant and clinically meaningful reduction in nasal polyp size and nasal congestion compared to placebo. The WAYPOINT trial is a randomized, double-blind study evaluating the efficacy and safety of subcutaneous Tezspire in adults with severe CRSwNP who remained symptomatic despite treatment with standard-of-care intranasal corticosteroids (INCS).
Dr. Joseph Han, co-primary investigator and Vice Chair of Rhinology & Endoscopic Sinus and Skull Base Surgery, Allergy, Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, US, noted, "Chronic rhinosinusitis with nasal polyps (search) negatively impact patients’ daily lives with obstructions leading to disturbances in smell, taste and sleep as well as pain and fatigue. 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."
Impact on Patient Burden
Dr. Brian Lipworth, co-primary investigator and Professor of Allergy and Pulmonology, Scottish Centre for Respiratory Research, Tayside Rhinology Ear, Nose and Throat Clinic, Ninewells Hospital University of Dundee in Scotland, UK, highlighted the burden faced by patients with nasal polyps (search), including repeat surgeries and frequent high-dose 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," he stated.
TSLP Inhibition
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, emphasized that the WAYPOINT trial results demonstrate the significant benefits of tezepelumab for patients with nasal polyps (search). She added, "These results reinforce that tezepelumab’s first-in-class mode of action, targeting TSLP (search) at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases."
The safety profile and tolerability of Tezspire in the WAYPOINT trial were consistent with its established profile. Full results from the trial will be presented to regulatory authorities and the scientific community at a future medical meeting.
WAYPOINT Trial Design
The WAYPOINT trial was a double-blind, multi-center, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of tezepelumab in adults with severe CRSwNP. Participants received either tezepelumab or placebo via subcutaneous injection. The trial included a 52-week treatment period and a post-treatment follow-up period of 12-24 weeks for participants who completed the treatment phase.
The co-primary endpoints were the change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and the change from baseline in bi-weekly mean nasal congestion, measured by the participant-reported Nasal Congestion Score, evaluated as part of the daily Nasal Polyposis Symptom Diary. Key secondary endpoints included loss of smell, improvement in disease-specific health-related quality of life (SNOT-22 score), Lund-Mackay score, time to surgery decision and/or systemic corticosteroids for nasal polyposis, time to nasal polyposis surgery decision, time to systemic corticosteroids for nasal polyposis, Nasal Polyposis Symptom Diary total symptom score, and pre-bronchodilator FEV1 at Week 52 in patients with comorbid asthma (search).
About Tezspire
Tezspire (tezepelumab) is a first-in-class human monoclonal antibody developed by AstraZeneca in collaboration with Amgen. It inhibits the action of thymic stromal lymphopoietin (TSLP (search)), a key epithelial cytokine at the top of multiple inflammatory cascades critical in the initiation and persistence of allergic, eosinophilic, and other types of airway inflammation associated with severe asthma (search). Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 countries and is available as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.