AstraZeneca and Amgen's Tezspire Shows Promise in Chronic Rhinosinusitis with Nasal Polyps

AstraZeneca and Amgen have announced positive results from their Phase III WAYPOINT trial, strengthening the case for expanding the use of Tezspire (tezepelumab) to treat chronic rhinosinusitis with nasal polyps (CRSwNP). The data, presented at the Joint Congress of the American Academy of Allergy Asthma & Immunology (AAAAI) and World Allergy Organization in San Diego, demonstrate significant improvements in key measures of nasal polyp burden and symptoms.

Tezspire Demonstrates Efficacy in Phase III Trial

The WAYPOINT trial met its co-primary endpoints, showing that Tezspire elicited a more than 2-point reduction in the Nasal Polyp Score (NPS) and lowered the patient-reported Nasal Congestion Score (NCS) by more than 1 point compared to placebo at 52 weeks. Both treatment effects were reported to be highly statistically significant.

In addition to the primary endpoints, Tezspire achieved success in key secondary outcomes, including:

• Reduced need for subsequent surgery by 98%
• Decreased use of systemic corticosteroids by 88%
• Improved time to first use of systemic glucocorticoids
• Enhanced sense of smell
• Better total symptom scores
• Increased time before patients opted for surgical removal of polyps

Mechanism of Action and Regulatory Outlook

Tezspire is a humanized IgG2 monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a cytokine crucial in the inflammatory cascade. By binding to TSLP and preventing its interaction with its receptor, Tezspire disrupts the inflammation pathway, potentially offering a novel approach to treating epithelial-driven inflammatory diseases.

Sharon Barr, executive vice president of biopharmaceuticals R&D at AstraZeneca, highlighted the potential of Tezspire to provide a much-needed option for CRSwNP patients, emphasizing its first-in-class mode of action.

AstraZeneca and Amgen are preparing to file regulatory submissions for Tezspire in CRSwNP in the first half of 2025. The drug is currently approved for severe asthma in patients aged 12 and above, based on positive results from the Phase III NAVIGATOR trial.

Future Directions and Market Implications

While the WAYPOINT results are promising, analysts at Leerink Partners noted that cross-study comparisons with competing treatments like Dupixent should be approached cautiously due to differences in trial designs and patient populations.

Beyond CRSwNP and asthma, AstraZeneca and Amgen are exploring Tezspire's potential in other inflammatory respiratory conditions, including chronic obstructive pulmonary disease and eosinophilic esophagitis. These ongoing studies underscore the partners' commitment to expanding Tezspire's therapeutic reach and solidifying its position in the treatment of inflammatory diseases.