The companies did not provide detailed data for Tezspire, however, and William Blair’s Matt Phipps said in a note he does not expect the antibody to outperform Dupixent.
AstraZeneca and Amgen on Friday announced that their subcutaneous antibody Tezspire (tezepelumab) met the primary endpoint in the Phase III WAYPOINT study, demonstrating significant efficacy in patients with chronic rhinosinusitis with nasal polyps.
The partners did not reveal specific data in their news release, only announcing that Tezspire resulted in a “statistically significant and clinically meaningful” decrease in the size of nasal polyps. Tezspire treatment also reduced nasal congestion, as compared with placebo, the companies said, while having a safety profile consistent with what had been established in prior studies of the drug, which was approved last year for severe asthma.
In a Friday note, however, William Blair analyst Matt Phipps pointed out that the partners’ press announcement “does not specifically state that the companies will file for approval” of Tezspire in chronic rhinosinusitis with nasal polyps (CRSwNP). “There could be some regulatory risk for Tezspire in CRSwNP, given that WAYPOINT is the only study that has evaluated Tezspire specifically in this indication.”
In contrast, Sanofi and Regeneron’s Dupixent (dupilumab)—one of the heaviest hitters in the anti-inflammatory space—was backed by two pivotal studies when the FDA granted it approval in 2019.
“Ahead of the full data, we do not expect Tezspire to necessarily beat Dupixent on efficacy,” Phipps said, particularly as patients with CRSwNP “almost exclusively have evidence of high type-2 inflammation,” which Dupixent targets. Meanwhile, Tezspire targets and inhibits the TSLP cytokine, which plays an important role in initiating and maintaining allergic, eosinophilic and other types of inflammation. TSLP signaling is commonly associated with asthma, chronic obstructive pulmonary disease and CRSwNP.
Still, “given that asthma and CRSwNP commonly present together, we believe inclusion of CRSwNP in [Tezspire’s] label, if approved, could lead to increased adoption in patients with overlapping disease,” Phipps added.
AstraZeneca and Amgen will share these data to regulatory authorities and present them at an upcoming medical congress, according to Friday’s news release.
Sharon Barr, executive vice president of BioPharmaceuticals R&D at AstraZeneca, in a statement said that the companies are “excited” about these findings, which “reinforce that tezepelumab’s first-in-class mode of action . . . effectively addresses the multiple drivers of epithelial-driven inflammatory diseases.”
Tezspire’s Phase III win on Friday follows GSK in September 2024 announced that its investigational anti-IL-5 antibody depemokimab reduced serious asthma attacks by more than 50% and lowered exacerbations needing hospitalization or emergency visits by 72%. Depemokimab, designed to be administered twice-yearly, is being assessed for severe asthma and CRSwNP, and GSK stated that it will coordinate its regulatory filings for these two indications.
