POSITIVE RESULTS FROM TEZSPIRE® (TEZEPELUMAB-EKKO) PHASE 3 WAYPOINT TRIAL HIGHLIGHT RAPID, SUSTAINED EFFECT IN CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

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PR Newswire

Sat, Mar 1, 2025, 3:30 PM 21 min read

THOUSAND OAKS, Calif., March 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced full results from the Phase 3, registrational WAYPOINT trial demonstrating that TEZSPIRE^®(tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery and systemic corticosteroid use in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps]) compared to placebo.^1,2 The data were published today in the New England Journal of Medicine and were highlighted as a late-breaking oral presentation during the American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego.^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 assessments, respectively) and were sustained through week 52.¹

"Chronic rhinosinusitis with nasal polyps is a recurrent condition often requiring repeat courses of systemic corticosteroids, even for patients on currently available biologics, and can require repeat surgeries," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "The WAYPOINT data highlight the potential of targeting inflammation at the epithelium to provide lasting relief for those with CRSwNP, adding to the efficacy profile that has been well established for TEZSPIRE in severe asthma."

Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population. Importantly, TEZSPIRE significantly reduced the need for nasal polyp surgery by 98% (; p<0.0001) and the need for systemic corticosteroid treatment by 88% (; p<0.0001) compared to placebo.¹

"Many patients living with nasal polyps are at risk of repeat surgeries and serious systemic side effects from long-term oral corticosteroids," said Dr. Joseph Han, vice chair of rhinology & endoscopic sinus and skull base surgery, and allergy, otolaryngology-head and neck surgery, Eastern Virginia Medical School, and co-primary investigator in the trial. "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."

Table 1: Summary of co-primary and key secondary efficacy endpoints^1,2

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 0-10)*	-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 endpoints: Assessed in a subset of patients with comorbid 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 invterval) is presented for the difference vs placebo.

In patients with CRSwNP, TEZSPIRE 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

TEZSPIRE^® (tezepelumab-ekko) U.S. 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.

TEZSPIRE^® (tezepelumab-ekko) Important Safety Information
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (e.g., 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 (i.e., 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 the full Prescribing Information including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products by clicking here.

About TEZSPIRE^® (tezepelumab-ekko)
TEZSPIRE is a 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, TEZSPIRE targets and blocks 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.^18,19TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.

Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.^8,18Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.^18-20 By working at the top of the cascade, TEZSPIRE helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.^10,18,21

TEZSPIRE is currently approved for the treatment of severe asthma in the U.S., Europe, Japan, and more than 50 countries across the globe.^22-25 It is approved as a pre-filled, single-use pen and auto-injector for self-administration in the U.S. and Europe.^{22, 23}

Beyond severe asthma and CRSwNP, TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).^26,27 Regulatory filings for TEZSPIRE in CRSwNP are currently under review by regulatory authorities in multiple regions. In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE. In July 2024, the U.S. FDA granted a Breakthrough Therapy Designation for tezepelumab for the add-on maintenance treatment of patients with moderate to very severe COPD characterised by an eosinophilic phenotype.

About Chronic Rhinosinusitis with Nasal Polyps (CRSwNP [nasal polyps])
CRSwNP is a complex inflammatory disorder characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.^4,5Nasal polyps 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.^6-8

Epithelial dysfunction and inflammation are important characteristics of chronic rhinosinusitis and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment.⁹ Estimates suggest that up to 56% of patients with CRSwNP have comorbid asthma. Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been implicated in shared pathophysiological processes underlying severe asthma and CRSwNP.^10,11

Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologic medication.^5,8,12-17

About the Phase 3 WAYPOINT Trial
WAYPOINT is a double-blind, multi-center, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with severe CRSwNP.^1,2,3 Participants received tezepelumab or placebo, administered via subcutaneous injection. The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.^1,2,3

The co-primary endpoints of the trial were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion, measured by the participant-reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary.³

Key secondary endpoints included loss of smell; improvement in disease-specific health-related quality of life as measured by SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery decision and/or systemic corticosteroids for nasal polyposis; time to nasal polyposis surgery decision; time to systemic corticosteroids for nasal polyposis; Nasal Polyposis Symptom Diary total symptom score and pre-bronchodilator FEV1 in patients with comorbid asthma and aspirin-exacerbated respiratory disease/NSAID-exacerbated respiratory disease (NSAID-ERD) at Week 52.³

About the Amgen and AstraZeneca Collaboration
In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for TEZSPIRE. 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, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada. AstraZeneca leads commercialization for TEZSPIRE outside North America.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads.

Amgen Forward-Looking Statements
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CONTACT: Amgen, Thousand Oaks
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