After announcing a successful primary endpoint in November, AstraZeneca and Amgen presented the full data on their severe asthma antibody candidate on Friday.
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After announcing a successful primary endpoint in November, AstraZeneca and Amgen presented the full data on their severe asthma antibody candidate on Friday.
The Phase III double-blinded trial, NAVIGATOR, showed the duo’s potentially first-in-class medicine tezepelumab to significantly reduce the annual asthma exacerbation rate (AAER) in severe, uncontrolled asthma patients. Over a 52-week period, the drug achieved a 56% reduction in patient’s AAER compared to the placebo, when added to Standard of Care corticosteroids and controller medication. The drug proved it could make a significant difference in patients with all levels of eosinophils, even those with high levels, a feature of persistent inflammation associated with increased asthma attacks.
Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, U.K., and principal investigator of the NAVIGATOR Phase III trial, said: “These are ground-breaking results for the many patients with severe asthma who continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics. Tezepelumab has the potential to transform treatment for a broad population of patients with severe asthma regardless of their type of inflammation, including those with and without an eosinophilic phenotype.”
The virtual annual meeting of the American Academy of Asthma, Allergy and Immunology got the full presentation.
Asthma affects an estimated 339 million people globally. Approximately 5-10% of those cases are considered severe asthma, unable to be consistently controlled despite use of controller medicine and current biologic therapies.
Due to the demand for better treatments, AstraZeneca and Amgen snagged Breakthrough Therapy Designation for tezepelumab back in September 2018. With these Phase III results along with the FDA special designation, the companies are well positioned for a speedy filing for FDA approval.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “The unprecedented results from the NAVIGATOR Phase III trial show tezepelumab is the first and only asthma biologic to demonstrate in randomized trials clinically meaningful exacerbation reductions, irrespective of blood eosinophil counts, allergy status and fractional exhaled nitric oxide. There is now a strong body of evidence showing the benefit of targeting the top of the inflammatory cascade with tezepelumab, and we look forward to bringing this potential first-in-class medicine to a broad population of severe asthma patients as soon as possible.”
Tezepelumab is a once-a-month injectable monoclonal antibody that is the first to show benefit for severe asthma patients by targeting TSLP. TSLP is a key epithelial cytokine that is critical in the initiation and lingering effects of airway inflammation associated with severe asthma. In addition to the primary efficacy endpoint of AAER reduction, secondary endpoints of lung function, asthma control and quality of life also demonstrated superiority to the placebo.
One mark against tezepelumab was a flopped Phase III SOURCE trial announced in December. The primary endpoint of that trial was to reduce patients’ dependence on corticosteroids. The company execs called the results “surprising” due to the strong positive data from the NAVIGATOR study. VP of Amgen R&D suggested study design to be a contributing factor. Full results have not yet been released.
This does presumably cause a wrinkle in the company’s plans to give Sanofi and Regeneron’s Dupixent a run for its money. Dupixent’s trials did show a reduction in the number of corticosteroids patients needed while on their drug.
Patients in AZ and Amgen’s SOURCE and NAVIGATOR trials will be eligible to continue in DESTINATION, a Phase III trial assessing long-term efficacy and safety.
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