Six months after Amgen and AstraZeneca reported promising results for Tezspire (tezepelumab) as a potential treatment for chronic obstructive pulmonary disorder (COPD), the companies are touting the ability of the anti-inflammatory antibody in another indication.
A phase 3 study has shown that when compared with placebo, Tezspire provided a statistically significant and clinically meaningful reduction in polyp size and nasal congestion in patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP), who are symptomatic despite treatment with standard-of-care intranasal corticosteroids.
The companies will present the results at an upcoming conference as they try to expand the patient population for Tezspire, which was initially approved to treat asthma in 2021.
Tezspire is a monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine, which triggers inflammation. TSLP is released in response to allergens, viruses and other airborne particles associated with asthma, COPD, CRSwNP, eosinophilic esophagitis (EoE) and other diseases.
“These results reinforce that tezepelumab’s first-in-class mode of action, targeting TSLP at the top of the inflammatory cascade, effectively addresses the multiple drivers of epithelial-driven inflammatory diseases,” Sharon Barr, AZ’s biopharma R&D chief, said in a release.
In the WAYPOINT study, patients received subcutaneous injections of Tezspire every four weeks for a year with a 12- and 24-week follow-up. The co-primary endpoints were changed from baseline in total nasal polyp size and in bi-weekly mean nasal congestion.
“Patients diagnosed with nasal polyps continue to experience significant burden including repeat surgeries and frequent treatment with high doses of oral corticosteroids, which are associated with serious systemic side effects," Brian Lipworth, the trial's co-primary investigator said. "The tezepelumab data are clinically meaningful and offer patients with nasal polyps hope for a potential new treatment option that may reduce the burden on patients and healthcare systems.”
Last month, GSK reported that its highly touted investigational asthma treatment depemokimab reduced nasal polyps in two phase 3 trials of CRSwNP patients, which had the same primary endpoints as the WAYPOINT study. Like AZ and Amgen, GSK is waiting to reveal the data at an upcoming medical meeting.
In May, Amgen and AZ revealed that a phase 2a trial showed the effectiveness of Tezspire in certain patients with COPD. The study did not meet its primary objective but in those with blood eosinophil counts (BEC) of 150 cells or greater/µL (per microliter), Tezspire provided a 37% reduction in moderate or severe exacerbations.
Since its approval to treat asthma three years ago, Tezspire has generated increasing sales. AZ reported combined Tezspire sales of $507 million for the two companies in the first half of this year, almost doubling the $257 million from the same period last year.