AZN: TEZSPIRE Reduces Nasal Polyp Severity And Surgery Need In CRSwNP Patients In Phase III Trial

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(RTTNews) - The Phase III WAYPOINT trial results revealed that AstraZeneca (AZN.L, AZN) and Amgen's (AMGN) TEZSPIRE (tezepelumab-ekko) significantly decreased nasal polyp severity, reduced the necessity for subsequent surgeries, and minimized systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) compared to placebo.

According to the companies, treatment with TEZSPIRE significantly reduced nasal polyp severity measured by the co-primary endpoints; Nasal Polyp Score (NPS) by -2.065 and nasal congestion (measured by participant-reported Nasal Congestion Score [NCS]) by -1.028 at week 52 compared to placebo.Improvements in NPS were observed as early as week four and NCS as early as week two and were sustained through week 52.

The companies noted that statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population. Importantly, TEZSPIRE significantly reduced the need for subsequent nasal polyp surgery by 98% and the need for systemic corticosteroid treatment by 88% compared to placebo.

TEZSPIRE was generally well tolerated in patients with CRSwNP and had a safety profile consistent with its approved severe asthma indication.The most frequently reported adverse events for TEZSPIRE in the WAYPOINT trial were COVID-19, nasopharyngitis and upper respiratory tract infection. There were no clinically meaningful differences in safety results between the TEZSPIRE and placebo group.

TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan, and over 60 countries across the globe. It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU. Regulatory filings for tezepelumab in CRSwNP are currently under review by regulatory authorities in multiple regions.

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