Tezspire Meets Co-Primary Endpoints in Phase 3 Trial for Chronic Rhinosinusitis with Nasal Polyps
Key Insights
The Phase 3 WAYPOINT trial demonstrated that Tezspire significantly reduced nasal polyp size in patients with chronic rhinosinusitis with nasal polyps (search) (CRSwNP).
Tezspire also significantly reduced nasal congestion compared to placebo in patients with CRSwNP, showing clinically meaningful improvements.
The safety and tolerability profile of Tezspire in the WAYPOINT trial were consistent with its known profile, reinforcing its potential as a treatment option.
Amgen and AstraZeneca's Tezspire (tezepelumab-ekko (search)) has demonstrated positive top-line results in the Phase 3 WAYPOINT trial for patients with chronic rhinosinusitis with nasal polyps (search) (CRSwNP). The trial met both co-primary endpoints, showing a statistically significant and clinically meaningful reduction in nasal polyp size and nasal congestion compared to placebo. The safety profile of Tezspire in the trial was consistent with its known profile.
WAYPOINT is a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Tezspire, administered subcutaneously in adults with severe CRSwNP. Participants in the trial were symptomatic despite treatment with standard of care, intranasal corticosteroids (INCS).
Impact on Patient Lives
Dr. Joseph Han, vice chair of Rhinology & Endoscopic Sinus and Skull Base Surgery, and Allergy, Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School, US, and co-primary investigator in the trial, noted, "Chronic rhinosinusitis with nasal polyps (search) negatively impact patients' daily lives with the obstructions leading to disturbances in smell, taste and sleep, as well as pain and fatigue." He added, "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."
Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen, stated, "The top-line results from our Phase 3 WAYPOINT study represent a significant step forward in our commitment to enhancing the lives of those affected by chronic rhinosinusitis with nasal polyps (search)." He further explained that the data highlight tezepelumab's unique capacity to target multiple inflammatory pathways by acting directly at the epithelium, resulting in meaningful symptom relief that can improve patients' daily experiences.
Addressing Unmet Needs
Dr. Brian Lipworth, Professor of Allergy and Pulmonology, Scottish Centre for Respiratory Research, and Tayside Rhinology Ear, Nose and Throat Clinic, Ninewells Hospital University of Dundee in Scotland, UK, and co-primary investigator in the trial, commented, "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." He emphasized that 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.
The full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.
Trial Design and Endpoints
The WAYPOINT trial included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period. 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 as measured by SinoNasal Outcome Test (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 in patients with comorbid asthma (search) and aspirin-exacerbated respiratory disease/NSAID-exacerbated respiratory disease (NSAID-ERD) at Week 52.
About Chronic Rhinosinusitis with Nasal Polyps
CRSwNP is characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps. These polyps can block nasal passages, leading to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance, and other adverse effects on quality of life. Estimates suggest that up to 56% of patients with CRSwNP have comorbid asthma (search). Thymic stromal lymphopoietin (search) (TSLP (search)) is an epithelial cytokine implicated in shared pathophysiological processes underlying severe asthma and CRSwNP.
Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery, and biologic medication.
About Tezspire
Tezspire is a first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (search) (TSLP (search)), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. By blocking TSLP, Tezspire may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma (search) exacerbations and improved asthma control. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and more than 50 countries. It is also in development for other potential indications including chronic obstructive pulmonary disease (COPD (search)) and eosinophilic esophagitis (search) (EoE).