POSITIVE RESULTS FROM TEZSPIRE® (TEZEPELUMAB-EKKO) PHASE 3 WAYPOINT TRIAL HIGHLIGHT RAPID, SUSTAINED EFFECT IN CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

Core Insights - The Phase 3 WAYPOINT trial results demonstrate that TEZSPIRE (tezepelumab-ekko) significantly reduces nasal polyp severity, the need for surgery, and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo [1][2][17] Efficacy Results - TEZSPIRE treatment resulted in a reduction of the Nasal Polyp Score (NPS) by -2.065 and nasal congestion by -1.028 at week 52 compared to placebo, with both results being statistically significant (p<0.0001) [1][2] - Improvements in NPS were observed as early as week four and in nasal congestion as early as week two, with effects sustained through week 52 [1][2] - The need for nasal polyp surgery was reduced by 98% and the need for systemic corticosteroid treatment was reduced by 88% compared to placebo, both statistically significant (p<0.0001) [1][2] Secondary Outcomes - Statistically significant improvements were noted across all key secondary outcomes, including loss of smell, quality of life (measured by SNOT-22), and sinus CT scores [2][17] - The time to first nasal polyp surgery decision and systemic glucocorticoid use was significantly longer in the TEZSPIRE group compared to placebo [2][17] Safety Profile - TEZSPIRE exhibited a safety profile consistent with its approved indication for severe asthma, with the most frequently reported adverse events being COVID-19, nasopharyngitis, and upper respiratory tract infections [3][14] Indications and Future Development - TEZSPIRE is currently indicated for the add-on maintenance treatment of severe asthma and is under review for CRSwNP in multiple regions [3][14] - The drug is also being developed for other potential indications, including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE) [14][18] Collaboration Details - Amgen and AstraZeneca have a collaboration agreement for TEZSPIRE, sharing costs and profits equally, with AstraZeneca leading development and commercialization outside North America [18][19]