Amgen and AstraZeneca announced positive top-line results from the Phase 3 WAYPOINT trial, evaluating Tezspire (tezepelumab-ekko) in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The trial met both co-primary endpoints, demonstrating statistically significant and clinically meaningful reductions in nasal polyp size and nasal congestion compared to placebo.
The WAYPOINT trial was a randomized, double-blind, placebo-controlled study involving patients with severe CRSwNP who remained symptomatic despite treatment with standard-of-care intranasal corticosteroids (INCS). Participants received subcutaneous injections of Tezspire or placebo. 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.
Key Findings from the WAYPOINT Trial
The trial's results indicate that Tezspire significantly improved both polyp size and nasal congestion, two key indicators of CRSwNP severity. According to Dr. Joseph Han, co-primary investigator in the trial, the data demonstrate tezepelumab's potential as a new treatment for patients whose lives are disrupted by this debilitating disease. Dr. Brian Lipworth, another co-primary investigator, noted that the 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.
Impact on Patient Quality of Life
CRSwNP is characterized by persistent inflammation of the nasal mucosa and the growth of soft tissue masses called nasal polyps. These polyps can obstruct nasal passages, leading to breathing difficulties, impaired sense of smell and taste, nasal discharge, facial pain, and sleep disturbances. Current treatments include intranasal and systemic corticosteroids, surgery, and biologic medications. However, many patients continue to experience significant burden, including repeat surgeries and frequent use of oral corticosteroids, which are associated with serious systemic side effects.
Tezspire's Mechanism of Action
Tezspire is a first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a key epithelial cytokine involved in multiple inflammatory cascades. By blocking TSLP, Tezspire acts on the primary source of inflammation, potentially preventing the release of pro-inflammatory cytokines and improving disease control. Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen, highlighted tezepelumab's unique capacity to target multiple inflammatory pathways by acting directly at the epithelium, resulting in meaningful symptom relief.
Further Development and Regulatory Plans
The full results of the WAYPOINT trial will be shared with regulatory authorities and the scientific community at an upcoming medical meeting. Tezspire is currently approved for the treatment of severe asthma in multiple countries, and is also in development for other potential indications including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).
