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Tezspire Phase III Nasal Polyp Data May Lead To Second Indication

 
• By Joseph Haas

AstraZeneca and Amgen’s first-in-class anti-TSLP agent Tezspire, already approved for severe asthma, has shown an ability to reduce the size of nasal polyps and improve congestion.

AstraZeneca and Amgen hope to file Tezspire for nasal polyps with Phase III readout (Shutterstock)

AstraZeneca and Amgen are holding most of their cards close to the vest, but Phase III data they reported on 8 November may be adequate to file their anti-TSLP agent Tezspire (tezepelumab) for a second indication, in chronic rhinosinusitis with nasal polyps (CRSwNP). The drug met statistical significance in the WAYPOINT trial with clinically meaningful reduction of nasal polyp size and related nasal congestion.

Key Takeaways
  • AstraZeneca and Amgen will seek to file Tezspire for nasal polyps related to chronic rhinosinusitis based on a successful Phase III trial.
  • Although no numerical data were disclosed from WAYPOINT, the companies said Tezspire reduced the size of nasal polyps and decreased related congestion

The two companies are not providing numerical data from the 416-patient, placebo-controlled study as of yet, saying they will wait to report additional details at a future medical meeting, but in an interview executives from both companies said they will discuss the WAYPOINT data with regulators around the globe to see if they can file for approval based on a single Phase III study. Tezspire is the

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