Tezspire Achieves Both Primary Goals in Phase III WAYPOINT Trial for Chronic Rhinosinusitis with Nasal Polyps

AstraZeneca and Amgen announced promising top-line results from the Phase III WAYPOINT trial, showing that Tezspire (tezepelumab) significantly reduced nasal polyp size and congestion in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.

The WAYPOINT trial, a randomized, double-blind study, evaluated Tezspire administered subcutaneously in adults with severe CRSwNP who continued to experience symptoms despite standard treatments, such as intranasal corticosteroids.

Dr. Joseph Han, co-primary investigator and Vice Chair of Rhinology & Endoscopic Sinus and Skull Base Surgery at Eastern Virginia Medical School, highlighted the trial’s results: “CRSwNP disrupts daily life with symptoms that affect smell, taste, sleep, and overall quality of life. The data show Tezspire’s potential as a new treatment for those struggling with this debilitating condition.”

Dr. Brian Lipworth, co-primary investigator and Professor of Allergy and Pulmonology at the Scottish Centre for Respiratory Research, also noted the impact of CRSwNP, which often requires repeated surgeries and frequent high-dose oral corticosteroids, leading to serious side effects. He emphasized the clinical significance of the Tezspire data, which offers hope for a new treatment option that could lessen the burden on both patients and healthcare systems.

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, commented, “The WAYPOINT results highlight Tezspire’s benefits in patients with nasal polyps, underscoring its unique ability to target TSLP at the top of the inflammatory cascade, addressing multiple drivers of inflammation.”

The safety and tolerability of Tezspire in the trial were consistent with its known profile. Detailed findings will be shared with regulatory bodies and the scientific community in upcoming medical meetings.

Currently approved for severe asthma in the U.S., EU, Japan, and nearly 60 other countries, Tezspire is available as a single-use pre-filled syringe and auto-injector for self-administration in the U.S. and EU.

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