A Phase III trial, WAYPOINT, has yielded positive results for AstraZeneca and Amgen’s TEZSPIRE (tezepelumab) in treating chronic rhinosinusitis with nasal polyps (CRSwNP). The randomized, double-blind trial demonstrated that TEZSPIRE significantly reduced nasal polyp size and nasal congestion compared to a placebo in adults with severe CRSwNP. Participants were symptomatic despite receiving standard intranasal corticosteroid treatment.
CRSwNP significantly impacts patients’ daily lives. Nasal polyps obstruct nasal passages, causing breathing difficulties, reduced smell and taste, sleep disturbances, pain, and fatigue. The WAYPOINT trial results suggest that tezepelumab could be a new treatment option for this debilitating condition.
Current treatments for CRSwNP, including intranasal and systemic corticosteroids, surgery, and other biologics, often involve repeat surgeries and high doses of oral corticosteroids, leading to potentially serious systemic side effects. Tezepelumab offers a potential alternative that may lessen the burden on patients and healthcare systems.
The positive WAYPOINT results highlight tezepelumab’s unique mechanism of action. By targeting thymic stromal lymphopoietin (TSLP), a key epithelial cytokine, the treatment addresses the root of the inflammatory cascade driving epithelial-driven inflammatory diseases like CRSwNP and severe asthma. This mechanism effectively tackles multiple inflammatory drivers, offering a broader approach than current treatments.
The safety and tolerability of TEZSPIRE in this trial aligned with the medicine’s established profile. Complete results will be presented to regulatory authorities and the scientific community. Currently, TEZSPIRE is approved in numerous countries, including the US, EU, and Japan, for severe asthma treatment. It’s available as a single-use pre-filled syringe and auto-injector for self-administration.
CRSwNP involves persistent inflammation of the nasal mucosa and the growth of nasal polyps. This inflammation and the resulting polyps can cause breathing problems, olfactory dysfunction, nasal discharge, facial pain, sleep disruption, and negatively impact quality of life. Epithelial dysfunction, a key characteristic of CRSwNP, weakens the epithelium’s protective barrier function. TSLP plays a significant role in the shared pathophysiological processes underlying both severe asthma and CRSwNP.
The WAYPOINT trial’s design was a double-blind, multicenter, randomized, placebo-controlled, parallel-group study. Adult participants with severe CRSwNP received either tezepelumab or a placebo via subcutaneous injection. The trial included a post-treatment follow-up period for participants completing the 52-week treatment phase. Co-primary endpoints measured changes from baseline in total nasal polyp size and nasal congestion. Key secondary endpoints included loss of smell, quality of life, and other disease-related measures.
TEZSPIRE, co-developed by AstraZeneca and Amgen, is a first-in-class human monoclonal antibody. It works by inhibiting TSLP, a cytokine crucial in initiating and maintaining the airway inflammation associated with severe asthma and CRSwNP. This collaboration involves shared costs and profits, with AstraZeneca leading development and Amgen leading manufacturing. Joint commercialization will occur in North America.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
