THOUSAND OAKS, Calif.,
Sept. 5, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today
announced new data from the pivotal NAVIGATOR Phase 3 trial
demonstrating that tezepelumab reduced exacerbations and improved
lung function and nasal symptoms in patients with severe,
uncontrolled asthma and comorbid nasal polyps.1
Tezepelumab is a potential first-in-class treatment that acts at
the top of the inflammatory cascade by targeting thymic stromal
lymphopoietin (TSLP), an epithelial cytokine, and has the
potential to treat a broad population of patients with severe
asthma.2,3 Tezepelumab is being developed by Amgen in
collaboration with AstraZeneca.
The pre-specified exploratory analysis evaluated the effect of
tezepelumab in NAVIGATOR patients with or without reported nasal
polyps (NP+ or NP−) in the past two years. The analysis showed
tezepelumab achieved an 86% reduction in the annualized asthma
exacerbation rate (AAER) in NP+ patients (95% CI: 70, 93) and 52%
(95% CI: 42, 61) in NP− patients over 52 weeks, compared to
placebo when added to standard of care (SoC).1
Tezepelumab improved lung function at week 52 in both groups of
patients with an increase in pre-bronchodilator forced expiratory
volume in one second (FEV1) of 0.20 L (95% CI: 0.02, 0.37) and
0.13 L (95% CI: 0.08, 0.18) versus placebo in NP+ and NP− patients,
respectively.1 Tezepelumab also achieved a clinically
relevant improvement in nasal polyp symptoms at week 52, as
measured by the Sinonasal Outcome Test (SNOT-22), reducing the
SNOT-22 score in NP+ patients by 9.6 points (95% CI: 0.9, 18.2)
versus placebo.1,4 The adjusted mean score reductions
from baseline for tezepelumab and placebo were 20.10 points (SE:
3.07) and 10.55 points (SE: 2.94). Baseline mean (sd) SNOT-22 score
was 49.4 (21.5) and 47.8 (19.0) for tezepelumab and placebo,
respectively.1
"This new analysis from NAVIGATOR is exciting for the up to one
in five severe asthma patients who have comorbid nasal polyps,"
said Professor Andrew Menzies-Gow,
director of the Lung Division, Royal Brompton Hospital,
London, UK, the principal
investigator of the NAVIGATOR trial. "The analysis shows
tezepelumab's ability to reduce exacerbations, improve lung
function and reduce the symptoms of nasal polyps in this comorbid
population who are typically more prone to asthma attacks, have an
increased likelihood of airway obstruction, and may have a worse
quality of life."
"We're thrilled to see significant reductions in exacerbations
experienced by patients with severe asthma and comorbid nasal
polyps as noted within the latest analysis of NAVIGATOR data," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "These results
further strengthen our confidence in tezepelumab's potential to
address a significant unmet need across a broad population of
patients with severe asthma, including those with comorbid nasal
polyps. We look forward to bringing this potentially transformative
treatment to patients soon."
These findings were presented at the European Respiratory
Society (ERS) International Congress 2021 between September 5-8. There were no clinically
meaningful differences in safety results between the tezepelumab
and placebo groups in the NAVIGATOR trial. The most frequently
reported adverse events with tezepelumab were nasopharyngitis,
upper respiratory tract infection and headache.5
Results from the NAVIGATOR Phase 3 trial were published in
the New England Journal of Medicine in
May 2021.5 A Phase 3
clinical trial, WAYPOINT, has been initiated to explore the
efficacy and safety of tezepelumab in adults with severe, chronic
rhinosinusitis with nasal polyps.6
About Severe Asthma
Globally, there are approximately
2.5 million patients with severe asthma who are uncontrolled or
biologic eligible, with approximately 1 million in
the U.S. Many patients with severe asthma have an
inadequate response to currently available biologics and oral
corticosteroids and thus fail to achieve asthma
control.7,8,9 Uncontrolled asthma occurs when
symptoms persist despite treatment. Severe, uncontrolled asthma is
debilitating with patients experiencing frequent exacerbations,
significant limitations on lung function and a reduced quality of
life. 7,8,9 Patients with severe uncontrolled asthma
have twice the risk of asthma-related
hospitalizations.10,11 There is also a significant
socio-economic burden with these severe uncontrolled asthma
patients accounting for 50% of asthma-related
costs.12
Multiple inflammatory pathways are involved in the pathogenesis
of asthma.13-15 Eosinophilic asthma, and more
broadly, T2 inflammation-driven asthma, accounts for about
two-thirds of patients with severe asthma.15 These
patients are typically characterized as having elevated levels of
inflammatory biomarkers, including blood eosinophils, serum IgE and
fractional exhaled nitric oxide
(FeNO).16,17 However, many patients do not fit the
criteria for eosinophilic or allergic asthma, may have unclear or
multiple drivers of inflammation, and may not qualify for or
respond well to a current biologic medicine.17
Nasal polyps are benign growths that arise from the mucosa of
the nose and paranasal sinuses.18 Up to 22% of severe
asthma patients have comorbid nasal polyps.19 Nasal
polyps can block nasal passages and lead to breathing problems,
reduction in the sense of smell, nasal discharge, sleep disturbance
and other adverse effects on quality of life.20-22
About the NAVIGATOR and the PATHFINDER Clinical Trial
Program
Building on the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program
included two trials, NAVIGATOR5,23 and
SOURCE.24,25 The program includes additional planned
mechanistic and long-term safety trials.26 In addition,
a Phase 3 clinical trial, WAYPOINT, has been initiated to explore
the efficacy and safety of tezepelumab in adults with severe,
chronic rhinosinusitis with nasal polyps.6
NAVIGATOR is a Phase 3, randomized, double-blinded,
placebo-controlled trial in 1,061 adults (18–80 years old) and
adolescents (12–17 years old) with severe, uncontrolled asthma, who
were receiving treatment with medium- or high-dose inhaled
corticosteroids (ICS) plus at least one additional controller
medication with or without OCS. Of the 1,061 randomized patients,
1,059 received either tezepelumab 210 mg (n=528) or placebo
(n=531). In total for this pre-specified exploratory analysis, 83
patients had NP in the past 2 years (tezepelumab 210 mg, n=42;
placebo, n=41) and 976 did not (tezepelumab 210 mg, n=486; placebo,
n=490). NAVIGATOR met the primary endpoint with tezepelumab added
to SoC demonstrating a statistically significant and clinically
meaningful reduction in the AAER over 52 weeks in the overall
patient population, compared to placebo added to SoC. The trial
also met the primary endpoint in the subgroup of patients with
baseline eosinophil counts less than 300 cells per microliter, with
tezepelumab demonstrating a statistically significant and
clinically meaningful reduction in AAER in that patient population.
Similar reductions in AAER were observed in the subgroup of
patients with baseline eosinophil counts less than 150 cells per
microliter.26,27
NAVIGATOR primary
endpoints5
|
Endpoint
|
Timepoint
|
Annual
Exacerbation Rate
|
Results
Tezepelumab added
to SoC vs placebo added to SoC
|
Tezepelumab
|
Placebo
|
AAER – overall
patient population
|
Over 52
weeks
|
0.93 (95% CI: 0.80,
1.07)
|
2.10 (95% CI: 1.84,
2.39)
|
56% reduction (95%
CI: 47, 63; p<0.001)
|
AAER – baseline
eosinophil counts < 300 cells/µL
|
Over 52
weeks
|
1.02 (95% CI: 0.84,
1.23)
|
1.73 (95% CI: 1.46,
2.05)
|
41% reduction (95%
CI: 25, 54; p<0.001)
|
NAVIGATOR
pre-specified exploratory analysis: AAER in patients with severe,
uncontrolled asthma with or without nasal polyps in the two years
before randomization1
|
Subgroup
|
AAER results over
52 weeks
Tezepelumab added
to SoC versus placebo added to SoC (relative risk reduction and
annualized exacerbation rates)
|
Severe uncontrolled
asthma with reported nasal polyps (NP+)
|
86% reduction (95%
CI: 70, 93) ·
Tezepelumab: 0.39 (95% CI: 0.21, 0.72) · Placebo: 2.76 (95% CI: 1.79, 4.28)
|
Severe uncontrolled
asthma without reported nasal polyps (NP-)
|
52% reduction (95%
CI: 42, 61) ·
Tezepelumab: 0.98 (95% CI: 0.84, 1.14)
· Placebo: 2.05
(95% CI: 1.79, 2.35)
|
NAVIGATOR
pre-specified exploratory analysis: Pre-bronchodilator FEV1
in patients with severe, uncontrolled asthma with or without nasal
polyps in the two years before
randomization1
|
Subgroup
|
Pre-bronchodilator
FEV1 over 52 weeks
Tezepelumab added
to SoC versus placebo added to SoC (LS mean difference and LS mean
change from baseline)
|
Severe uncontrolled
asthma with reported nasal polyps (NP+)
|
0.20 L (95% CI: 0.02,
0.37)
·
Tezepelumab: 0.32 (SE: 0.064)
·
Placebo: 0.13 (SE: 0.064)
|
Severe uncontrolled
asthma without reported nasal polyps (NP-)
|
0.13 L (95% CI: 0.08,
0.18)
·
Tezepelumab: 0.22 (SE: 0.019)
·
Placebo: 0.09 (SE: 0.019)
|
LS: Least-squares,
CI: Confidence interval, SE: Standard error
|
NAVIGATOR is the first Phase 3 trial to show benefit in severe
asthma irrespective of eosinophils by targeting the thymic stromal
lymphopoietin (TSLP). The U.S. Food and Drug
Administration Breakthrough Therapy Designation was granted to
tezepelumab in September 2018 for patients with severe
asthma, without an eosinophilic phenotype.
SOURCE is a Phase 3 multicenter, randomized, double-blinded,
parallel-group, placebo-controlled trial for 48 weeks in adult
patients with severe asthma who require continuous treatment with
ICS plus long-acting beta2-agonists (LABA), and chronic treatment
with maintenance OCS therapy. In the trial, patients were
randomized to receive tezepelumab 210 mg every four weeks or
placebo as add-on therapy, with patients maintained on their
currently prescribed ICS plus LABA, with or without other asthma
controller therapy.
Patients who participated in the NAVIGATOR and SOURCE trials
were eligible to continue in DESTINATION, a Phase 3 extension trial
assessing long-term safety and efficacy.28
About Tezepelumab
Tezepelumab is being developed by
AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen
collaboration below) as an investigational, potential
first-in-class human monoclonal antibody that works on the primary
source of inflammation: the airway epithelium, which is the first
point of contact for viruses, allergens, pollutants and other
environmental insults. Specifically, tezepelumab targets and blocks
thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that
sits at the top of multiple inflammatory cascades and initiates an
overreactive immune response to allergic, eosinophilic and other
types of airway inflammation associated with severe
asthma.2,29
TSLP is released in response to multiple triggers associated
with asthma exacerbations, including allergens, viruses and other
airborne particles.2,29 Expression of TSLP is increased
in the airways of patients with asthma and has been correlated with
disease severity.2,3 Blocking TSLP may prevent the
release of pro-inflammatory cytokines by immune cells, resulting in
the prevention of asthma exacerbations and improved asthma
control.2,3 By working at the top of the cascade,
tezepelumab helps stop inflammation at the source and has the
potential to treat a broad population of severe asthma
patients.2,3
About the Amgen and AstraZeneca Collaboration
In 2020,
Amgen and AstraZeneca updated the 2012 collaboration agreement for
tezepelumab. Both companies will continue to share costs and
profits equally after payment by AstraZeneca of a mid-single-digit
royalty to Amgen. AstraZeneca continues to lead development and
Amgen continues to lead manufacturing. All aspects of the
collaboration are under the oversight of joint governing bodies.
Under the amended agreement in North
America, Amgen and AstraZeneca will jointly commercialize
tezepelumab; Amgen will record sales in the U.S. and AstraZeneca
will record sales in Canada.
Outside the U.S., Amgen will record sales as collaboration
revenue.
Amgen Inflammation
Amgen brings therapies to millions
of people with inflammatory diseases, with a focus on serving unmet
patient needs. For those with debilitating moderate to severe
rheumatoid arthritis, psoriatic arthritis, moderate to severe
plaque psoriasis, ankylosing spondylitis, asthma, and other chronic
conditions, the suffering and needs are severe. Complex diseases of
inflammation have defied simple solutions, and the breadth of
inflammatory disease and the burden patients bear is not well
understood.
For more than two decades, Amgen has been committed to
advancing the science and the understanding around inflammation to
address the unmet patient needs that exist and expanding our
portfolio. We lead with science through discovery research that is
disease-agnostic and biology-first, modality-second. In doing so,
we have introduced and evolved novel therapies that have changed
the lives of patients.
Our commitment to patients is reflected not only in where we
have succeeded, but in where we have failed and opened new doors.
Throughout, we have remained dedicated to the principle of leading
with science, pursuing where pathways and promising discoveries in
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for patients are found. It's a commitment that extends beyond
introducing novel therapies. We are focused on improving the entire
patient journey.
About Amgen
Amgen is committed to
unlocking the potential of biology for patients suffering from
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