The partners are building toward a regulatory submission for Tezspire in chronic rhinosinusitis with nasal polyps in the first half of 2025.
While regulatory preparations are underway, powerhouse partners AstraZeneca and Amgen continue to beef up their case for the expansion of the subcutaneous antibody Tezspire into chronic rhinosinusitis with nasal polyps.
Full data from the Phase III WAYPOINT trial showed Tezspire could elicit a more than 2-point reduction in the Nasal Polyp Score (NPS) at 52 weeks versus placebo. Similarly, the biologic lowered patient-reported Nasal Congestion Score (NCS) by more than 1 point as compared with placebo. Both treatment effects were highly statistically significant, according to the companies’ announcement.
Aside from hitting its co-primary endpoints NPS and NCS, Tezspire also aced key secondary outcomes, including the time to first use of a systemic glucocorticoid, loss of smell, total symptom score and the time before patients decide to undergo surgical removal of their polyps. Tezspire also reduced the need for subsequent surgery by 98% and for systemic corticosteroids by 88%, according to the companies.
AstraZeneca and Amgen presented the data Saturday at a late-breaking oral presentation at the Joint Congress of the American Academy of Allergy Asthma & Immunology (AAAAI) and World Allergy Organization, held in San Diego.
In an investor note on Sunday, analysts at Leerink Partners also took the WAYPOINT readout as a positive for Amgen and AstraZeneca, noting that Tezspire “demonstrated marginally better efficacy cross-trial vs. Dupixent,” with better NPS and NCS improvements.
Still, the analysts cautioned that cross-study comparisons could be fraught, particularly given “trial inclusion differences.” WAYPOINT, in particular, “enrolled a more selective group regarding respiratory comorbidities, but a broader population in terms of prior surgery,” the analysts noted.
Sharon Barr, executive vice president of biopharmaceuticals R&D at AstraZeneca, said Saturday’s readout points to the “potential of Tezspire to provide a much-needed option for patients with chronic rhinosinusitis with nasal polyps (CRSwNP).”
“With its first-in-class mode of action, targeting TSLP [thymic stromal lymphopoietin] at the top of the inflammatory cascade, the data add to the body of evidence that tezepelumab can transform care for patients with epithelial-driven inflammatory diseases,” Barr added.
TSLP is a cytokine that is a crucial upstream player in the inflammatory cascade. Tezspire, a humanized IgG2 monoclonal antibody, works by binding to TSLP and preventing its interaction with its corresponding receptor, thereby disrupting the inflammation pathway.
This mechanism of action won it the FDA’s approval for severe asthma in December 2021, backed by data from the Phase III NAVIGATOR trial, where Tezspire significantly reduced the annualized rate of asthma exacerbations versus placebo, while also eliciting improvements in lung function, symptom burden, disease control and quality of life. Tezspire can only be used in patients aged 12 and above.
In its fourth-quarter business presentation, Amgen disclosed that it was preparing to file regulatory submissions for Tezspire in CRSwNP in the first half of 2025. Beyond asthma and CRSwNP, AstraZeneca and Amgen are studying Tezspire for other inflammatory respiratory indications, including chronic obstructive pulmonary disease and eosinophilic esophagitis.
