Amgen (AMGN), AstraZeneca (AZN) Say Tezepelumab Is First Biologic To Significantly Reduce Exacerbations In Broad Population Of Patients With Severe, Uncontrolled Asthma

February 26, 2021 9:01 AM EST

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(Updated - February 26, 2021 9:07 AM EST)

Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today announced positive full results from the pivotal NAVIGATOR Phase 3 trial, which showed the potential of tezepelumab to be a first-in-class medicine in severe asthma. When added to standard of care (SoC), tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma, compared to placebo.1 The results were presented at the American Academy of Asthma Allergy & Immunology Annual Meeting. NAVIGATOR is a pivotal Phase 3 trial that will form the basis of regulatory filing.

Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to placebo when added to SoC.2 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials.2-10

"We believe the full results of the NAVIGATOR trial are a breakthrough for the millions of people living with severe asthma," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The reduction in exacerbation rates tezepelumab demonstrated, regardless of eosinophil or allergic status, is impressive. We are thrilled with these results and what they could mean for patients suffering with severe asthma."

In a pre-specified analysis of the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, tezepelumab achieved a statistically significant and clinically meaningful 41% reduction (p<0.001) in AAER.2 Importantly, clinically meaningful reductions in AAER were also observed in two additional subgroups: a 39% reduction in patients with baseline eosinophil counts less than 150 cells per microliter and a 70% reduction in patients with greater than or equal to 300 cells per microliter.2

Additionally, clinically meaningful reductions in AAER compared to placebo were observed in the tezepelumab-treated patients irrespective of allergy status and fractional exhaled nitric oxide (FeNO) level, biomarkers used by clinicians to inform treatment options.2

"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," said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase 3 trial. "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."

Tezepelumab also demonstrated statistically significant improvements in every key secondary endpoint compared to placebo, including lung function measurements, asthma control, and health-related quality of life.2

There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and headache.2

Tezepelumab blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.3,10 NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma by targeting TSLP.2

The statistically significant and clinically meaningful exacerbation rate reductions demonstrated with tezepelumab in patients with baseline eosinophil counts less than 300 cells per microliter support the U.S. Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.2-3 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below).



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