TEZSPIRE significantly reduced nasal
congestion, polyp size and nearly eliminated the need for surgery
in patients with chronic rhinosinusitis with nasal polyps
WAYPOINT data published in New England
Journal of Medicine and highlighted as late-breaking oral
presentation at AAAAI/WAO 2025
Full results from the positive Phase III WAYPOINT trial showed
AstraZeneca and Amgen’s TEZSPIRE® (tezepelumab-ekko) significantly
reduced nasal polyp severity, the need for subsequent surgery, and
systemic corticosteroid use in patients with chronic rhinosinusitis
with nasal polyps (CRSwNP) compared to placebo.1,2 These data were
published in the New England Journal of Medicine and presented
today as a late-breaking oral presentation at the American Academy
of Allergy Asthma & Immunology (AAAAI)/World Allergy
Organization (WAO) Joint Congress in San Diego, CA.1,2
Treatment with TEZSPIRE significantly reduced nasal polyp
severity measured by the co-primary endpoints; Nasal Polyp Score
(NPS) by -2.065 (95% CI: -2.389, -1.742; p<0.0001) and nasal
congestion (measured by participant-reported Nasal Congestion Score
[NCS]) by -1.028 (95% CI: -1.201, -0.855; p<0.0001) at week 52
compared to placebo.1,2 Improvements in NPS were observed as early
as week four and NCS as early as week two (the first post-treatment
assessment respectively) and were sustained through week 52.1
Statistically significant and clinically meaningful improvements
were observed across all key secondary outcomes assessed in the
overall trial population.1 Importantly, TEZSPIRE significantly
reduced the need for subsequent nasal polyp surgery by 98%
(p<0.0001) and the need for systemic corticosteroid treatment by
88% ( p<0.0001) compared to placebo.1
Dr Joseph Han, Vice Chair of Department of Otolaryngology - Head
and Neck Surgery, Old Dominion University, US, and co-primary
investigator in the trial, said: “Many patients living with nasal
polyps are at risk of repeat surgeries and serious systemic side
effects from long-term oral corticosteroids. The WAYPOINT results
are clinically meaningful and suggest that tezepelumab could
greatly reduce the burden of nasal polyps for patients by nearly
eliminating the need for future surgery and corticosteroid use and
by significantly reducing nasal polyp size and congestion.”
Sharon Barr, Executive Vice President, BioPharmaceuticals
R&D said, “The WAYPOINT results demonstrate the potential for
TEZSPIRE to provide a much-needed option for patients with chronic
rhinosinusitis with nasal polyps. With its first-in-class mode of
action, targeting TSLP at the top of the inflammatory cascade, the
data add to the body of evidence that tezepelumab can transform
care for patients with epithelial-driven inflammatory
diseases.”
Table M1: Summary of co-primary and key secondary efficacy
endpoints1,2
Endpoint
Tezepelumab (n=203)
Placebo (n=205)
Difference vs. Placebo
(95% CI)
Co-primary endpoints
Total nasal polyp score (range 0-8)*
-2.458 (0.114)
-0.392 (0.118)
-2.065 (-2.389, -1.742)
p<0.0001**
Nasal congestion score (range 0-3)*
-1.743 (0.062)
-0.715 (0.064)
-1.028 (-1.201, -0.855)
p<0.0001**
Key secondary endpoints
Assessed in the overall trial
population
Time to first nasal polyp surgery
decision
(% patients)***
0.5 (0.0, 2.5)
22.1 (16.4, 28.2)
0.02 (0.00, 0.09)
p<0.0001**
Time to first systemic glucocorticoid
use
(% patients)***
5.2 (1.1, 14.7)
18.3 (13.3, 24.1)
0.12 (0.04, 0.27)
p<0.0001**
Time to nasal polyp surgery decision
and/or systemic glucocorticoid use
(% patients)***
5.7 (1.3, 15.0)
30.6 (24.2, 37.1)
0.08 (0.03, 0.17)
p<0.0001**
Loss of smell score
(range 0-3)*
-1.26 (0.06)
-0.26 (0.06)
-1.00 (-1.18, -0.83)
p<0.0001**
Sino-Nasal Outcome Test-22 (SNOT-22) total
score
(range 0-110)*
-45.02 (1.81)
-17.76 (1.84)
-27.26 (-32.32, -22.21)
p<0.0001**
Sinus Computed Tomography Lund–Mackay
(CT-LMK) score
(range 0-24)*
-6.27 (0.24)
-0.55 (0.24)
-5.72 (-6.39, -5.06)
p<0.0001**
Total Symptom Score (TSS)
(range 0-24)*
-10.39 (0.40)
-3.50 (0.41)
-6.89 (-8.02, -5.76)
p<0.0001**
Key secondary endpoint
Assessed in a subset of patients with
co-morbid asthma or nonsteroidal anti-inflammatory drug exacerbated
respiratory disease
Pre-bronchodilator forced expiratory
volume in 1 second (FEV1 in liters)*
0.02 (0.04)
0.03 (0.04)
-0.01 (-0.12, 0.11)
p=0.9362
*LS mean change (SE) from baseline at Week
52
**Denotes statistically significant at
0.01 level after adjustment for multiplicity. Unadjusted P-values
are presented
*** % patients from Kaplan Meier estimate
(95% confidence interval) is provided for each treatment group,
hazard ratio (95% confidence interval) is presented for the
difference vs placebo.
TEZSPIRE was generally well tolerated in patients with CRSwNP
and had a safety profile consistent with its approved severe asthma
indication.1,2 The most frequently reported adverse events for
TEZSPIRE in the WAYPOINT trial were COVID-19, nasopharyngitis and
upper respiratory tract infection.1 There were no clinically
meaningful differences in safety results between the TEZSPIRE and
placebo group.1
TEZSPIRE is currently approved for the treatment of severe
asthma in the US, EU, Japan, and over 60 countries across the
globe.3-5 It is approved as a single-use pre-filled syringe and
auto-injector for self-administration in the US and EU.3,4
Regulatory filings for tezepelumab in CRSwNP are currently under
review by regulatory authorities in multiple regions.
INDICATION AND LIMITATION OF USE / ISI
TEZSPIRE® (tezepelumab-ekko)
INDICATION
TEZSPIRE is indicated for the add-on maintenance treatment of
adult and pediatric patients aged 12 years and older with severe
asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm
or status asthmaticus.
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials
(eg, rash and allergic conjunctivitis) following the administration
of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported.
These reactions can occur within hours of administration, but in
some instances have a delayed onset (ie, days). In the event of a
hypersensitivity reaction, consider the benefits and risks for the
individual patient to determine whether to continue or discontinue
treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms,
acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly
upon initiation of therapy with TEZSPIRE. Reductions in
corticosteroid dose, if appropriate, should be gradual and
performed under the direct supervision of a physician. Reduction in
corticosteroid dose may be associated with systemic withdrawal
symptoms and/or unmask conditions previously suppressed by systemic
corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient’s response
against helminth infections. Treat patients with pre-existing
helminth infections before initiating therapy with TEZSPIRE. If
patients become infected while receiving TEZSPIRE and do not
respond to anti-helminth treatment, discontinue TEZSPIRE until
infection resolves.
Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has
not been evaluated. The use of live attenuated vaccines should be
avoided in patients receiving TEZSPIRE.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥3%) are
pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to
evaluate for any drug-associated risk of major birth defects,
miscarriage, or other adverse maternal or fetal outcomes. Placental
transfer of monoclonal antibodies such as tezepelumab-ekko is
greater during the third trimester of pregnancy; therefore,
potential effects on a fetus are likely to be greater during the
third trimester of pregnancy.
Please see full Prescribing Information,
including Patient Information and Instructions
for Use.
You may report side effects related to AstraZeneca products.
Notes
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
CRSwNP is a complex inflammatory disorder, characterized by
persistent inflammation of the nasal mucosa accompanied by benign
growths, called nasal polyps.6,7 Nasal polyps and the accompanying
inflammation can block nasal passages and lead to breathing
problems, difficulty in sense of smell, nasal discharge, facial
pain, sleep disturbance and other adverse effects on quality of
life.8-10 Current treatments for CRSwNP include intranasal and/or
systemic corticosteroids, surgery and biologics.7,10-16
Phase III WAYPOINT trial
WAYPOINT was a double-blind, multi-centre, randomized,
placebo-controlled, parallel group trial designed to evaluate the
efficacy and safety of tezepelumab in adults with severe
CRSwNP.1,2,17 Participants received tezepelumab or placebo,
administered via subcutaneous injection.1,2,17 The trial also
included a post-treatment follow-up period of 12-24 weeks for
participants who completed the 52-week treatment period.1,17
TEZSPIRE
TEZSPIRE® (tezepelumab) is being developed by AstraZeneca in
collaboration with Amgen as a first-in-class human monoclonal
antibody that inhibits the action of thymic stromal lymphopoietin
(TSLP), a key epithelial cytokine that sits at the top of multiple
inflammatory cascades and is critical in the initiation and
persistence of allergic, eosinophilic, and other types of
epithelial-driven inflammation associated with severe asthma and
other inflammatory diseases.18,19
TSLP is released in response to multiple epithelial triggers and
insults (including allergens, viruses, bacteria, smoke, air
pollution and other airborne particles) associated with asthma,
CRSwNP, chronic obstructive pulmonary disease (COPD), eosinophilic
esophagitis (EoE) and other diseases.19,20 Expression of TSLP is
increased in these patients and has been correlated with disease
severity.10,18 Blocking TSLP can prevent the release of
pro-inflammatory cytokines by immune cells, resulting in the
prevention of exacerbations and improved disease control.18,19,21
Tezepelumab acts at the top of the inflammatory cascade and
research indicates that targeting TSLP released by the airway and
gastrointestinal epithelium may be a potential approach to treating
other diseases in the future.18,22,23
TEZSPIRE is approved in the US, the EU and over 60 countries for
the add-on maintenance treatment of adult and pediatric patients
aged 12 years and older with severe asthma.3-5
Beyond CRSwNP, tezepelumab is also in development for other
potential indications including COPD and EoE.24,25 In October 2021,
tezepelumab was granted Orphan Drug Designation by the US Food and
Drug Administration (FDA) for the treatment of EoE. In July 2024,
the US FDA granted a Breakthrough Therapy Designation for
tezepelumab for the add-on maintenance treatment of patients with
moderate to very severe COPD characterized by an eosinophilic
phenotype.
Amgen collaboration
In 2020, Amgen and AstraZeneca updated a 2012 collaboration
agreement for TEZSPIRE. Both companies will continue to share costs
and profits equally after payment by AstraZeneca of a
mid-single-digit inventor 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, Amgen and
AstraZeneca will jointly commercialize TEZSPIRE in North America.
Amgen will record product sales in the US, with AZ recording its
share of US profits as Collaboration Revenue. Outside of the US,
AstraZeneca will record product sales, with Amgen recording profit
share as Other/Collaboration revenue.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development, and commercialization
of prescription medicines in Oncology, Rare Diseases, and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 125 countries, and its innovative
medicines are used by millions of patients worldwide. Please visit
www.astrazeneca-us.com and follow the Company on social media
@AstraZeneca
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- Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms,
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