TEZSPIRE met co-primary endpoints in Phase III WAYPOINT trial for chronic rhinosinusitis with nasal polyps

Positive results from the Phase III WAYPOINT trial have shown that AstraZeneca and Amgen's TEZSPIRE (tezepelumab) effectively reduces the size of nasal polyps and alleviates nasal congestion in patients with chronic rhinosinusitis with nasal polyps (CRSwNP), compared to placebo. This trial is a significant milestone for patients suffering from severe CRSwNP who have not responded to standard treatments, such as intranasal corticosteroids.

The WAYPOINT trial is a randomized, double-blind study that assessed the efficacy and safety of TEZSPIRE administered subcutaneously to adults with severe CRSwNP. The participants included in the trial continued to experience symptoms despite being treated with standard care.

Dr. Joseph Han, Vice Chair of Rhinology & Endoscopic Sinus and Skull Base Surgery at Eastern Virginia Medical School, and one of the co-primary investigators of the trial, emphasized the considerable negative impact of CRSwNP on patients' daily lives. This condition causes obstructions that affect the sense of smell, taste, sleep, and overall quality of life. Dr. Han highlighted the trial's results, which indicate TEZSPIRE's potential as a new treatment option for those struggling with this debilitating disease.

Dr. Brian Lipworth, Professor of Allergy and Pulmonology at Ninewells Hospital University of Dundee in Scotland, UK, and another co-primary investigator, noted the ongoing burden faced by patients with nasal polyps. Many patients undergo repeated surgeries and frequent treatments with high doses of oral corticosteroids, which come with serious systemic side effects. Dr. Lipworth stated that the trial's data is promising, offering hope for a new treatment that could lessen the burden on patients and healthcare systems.

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, expressed excitement over the positive results, which underscore TEZSPIRE's unique mode of action. By targeting TSLP at the top of the inflammatory cascade, TEZSPIRE addresses multiple drivers of epithelial-driven inflammatory diseases effectively.

The safety and tolerability of TEZSPIRE in the WAYPOINT trial were consistent with its known profile. These findings will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.

TEZSPIRE is already approved for the treatment of severe asthma in the US, EU, Japan, and nearly 60 other countries. It is available as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.

CRSwNP is a chronic inflammatory disease characterized by persistent inflammation of the nasal mucosa and the presence of benign growths called nasal polyps. These polyps can obstruct nasal passages, leading to difficulties in breathing, loss of smell, nasal discharge, facial pain, and disturbances in sleep. Epithelial dysfunction and inflammation are key features of CRSwNP.

The WAYPOINT trial, a double-blind, multi-center, randomized, placebo-controlled study, aimed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP. Participants received either tezepelumab or a placebo through subcutaneous injections. The trial included a post-treatment follow-up period of 12-24 weeks after the 52-week treatment period.

The co-primary endpoints of the trial were changes from baseline in total nasal polyp size and bi-weekly mean nasal congestion. Key secondary endpoints included improvement in the sense of smell, disease-specific health-related quality of life, time to surgery decision and/or systemic corticosteroids for nasal polyposis, and time to nasal polyposis surgery decision.

TEZSPIRE is a first-in-class human monoclonal antibody developed by AstraZeneca in collaboration with Amgen. It inhibits the action of TSLP, a key cytokine involved in initiating and sustaining allergic and eosinophilic inflammation. TEZSPIRE is approved for the treatment of severe asthma in various countries.

The collaboration between Amgen and AstraZeneca involves shared costs and profits, with AstraZeneca leading development and Amgen leading manufacturing. The partnership aims to commercialize TEZSPIRE effectively in North America and other regions.

AstraZeneca continues to be a leader in respiratory care, driven by a commitment to address unmet needs in chronic respiratory and immune-mediated diseases through innovative medicines and research. The company’s goal is to improve the lives of patients dealing with these chronic conditions.