NEW DATA PRESENTED AT ATS 2024 SHOW THE POTENTIAL OF TEZSPIRE® TO HELP PATIENTS LIVING WITH COPD
On May 19, 2024, Amgen and AstraZeneca announced results from the Phase 2a COURSE trial evaluating Tezspire® (tezepelumab-ekko) for COPD. Although the primary endpoint showed a non-significant 17% reduction in COPD exacerbations compared to placebo, notable improvements were observed in specific patient subgroups. Patients with blood eosinophil counts (BEC) ≥150 cells/μL experienced a 37% reduction in exacerbations, while those with BEC ≥300 cells/μL saw a 46% reduction. Tezspire also improved lung function and quality of life. Safety profiles were consistent with previous findings for severe asthma.
- Tezspire showed a 37% reduction in COPD exacerbations for patients with BEC ≥150 cells/μL.
- Tezspire demonstrated a 46% reduction in COPD exacerbations for patients with BEC ≥300 cells/μL.
- Improvements in lung function were noted with increases of 63 mL and 146 mL in FEV1 for BEC ≥150 and ≥300 cells/μL respectively.
- Quality of life scores improved significantly, with reductions of 4.2 points and 9.5 points in SGRQ for BEC ≥150 and ≥300 cells/μL respectively.
- Amgen is planning a Phase 3 clinical program to further evaluate Tezspire in COPD patients.
- The primary endpoint of a 17% reduction in COPD exacerbations compared to placebo was not statistically significant.
- Tezspire did not show significant efficacy in patients with BEC <150 cells/μL.
- The most frequently reported adverse events included worsening of COPD (12.1%) and COVID-19 infections (14.5%).
Insights
The Phase 2a COURSE trial results for Tezspire present mixed outcomes regarding its efficacy in reducing moderate to severe exacerbations in COPD patients. Notably, Tezspire's impact is more pronounced in patients with elevated eosinophil counts, specifically those with ≥150 cells/µL and ≥300 cells/µL. These subgroups displayed a 37% and 46% reduction in exacerbation rates, respectively. This finding aligns with existing medical knowledge that elevated eosinophils in COPD patients often correlate with more severe disease and may respond better to biologics targeting eosinophilic pathways.
While the broader patient population did not achieve statistical significance, the subdivision analysis offers a promising avenue for targeted therapies, especially for bio-eligible patients who represent around
However, it is essential to notice that the overall reduction in exacerbations in the broader patient population was
The safety profile remains consistent with prior indications, showing the most common adverse events as COPD worsening and COVID-19 infections, which is expected considering the trial started in 2019.
The results from this Phase 2a trial of Tezspire present an interesting market opportunity for both Amgen and AstraZeneca. The biotech market is highly competitive, particularly in the respiratory disease segment, with significant stakes in developing effective therapies for COPD. The potential for Tezspire to address unmet needs in COPD patients, specifically those with higher eosinophil counts, could offer a competitive edge and drive future revenue streams.
However, the mixed results will likely temper immediate investor enthusiasm. The overall
Strategically, the involvement of Amgen and AstraZeneca in these trials signifies a robust commitment to advancing Tezspire, which could eventually lead to a significant market share in the COPD treatment landscape. Investors should keep an eye on the progression of Phase 3 trials and regulatory milestones as they will be critical in determining the commercial viability of Tezspire.
From a financial perspective, the results of the Phase 2a COURSE trial position Tezspire as a potentially valuable asset for Amgen and AstraZeneca, but with some caveats. The nuanced efficacy data, particularly in subgroups with high eosinophil counts, suggests potential market segmentation that could be beneficial. However, the broader patient cohort not achieving statistical significance in exacerbation reduction may impact short-term investor sentiment and stock performance.
Given that the trial outcomes indicate efficacy in specific sub-populations, this could lead to targeted marketing strategies, potentially enhancing cost-efficiency and return on investment. The impending Phase 3 trials will be critical; positive outcomes here could significantly enhance the drug's market potential and drive stock valuation positively.
It's also important to consider the competitive landscape. Any delays or negative outcomes in subsequent trials could give competitors an edge. Moreover, the safety profile being consistent with previous indications is positive, as it mitigates additional development risks associated with adverse events.
Overall, while there is a basis for cautious optimism, the true financial impact will hinge on the results of the upcoming Phase 3 trials and eventual regulatory approvals.
Late-Breaking Results From the Phase 2a COURSE Trial Illustrate Tezspire's Impact on COPD Exacerbations in Patients With a Broad Range of Eosinophil Levels
Importantly, this proof-of-concept study showed that, in patients with BEC ≥150 cells/µL, tezepelumab led to a nominally significant reduction of
"Despite advances in treatments for patients with COPD, there is still a pressing need for effective therapies that can improve their clinical outcome, especially for those with eosinophil counts above 150 cells/µL," said Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at Amgen. "We are now actively planning a Phase 3 clinical program evaluating tezepelumab in patients with COPD."
A subgroup analysis of the COURSE trial also showed treatment with tezepelumab resulted in numerical improvements in lung function as measured by forced expiratory volume (FEV1) (improvement of 63 mL and 146 mL in BEC ≥150 and ≥300 cells/μL respectively, compared to placebo) and in quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) score (reduction of 4.2 points and 9.5 points in BEC ≥150 and ≥300 cells/μL respectively). The safety and tolerability profile for tezepelumab was consistent with its approved severe asthma indication; the most frequently reported (>
"I believe biologics will play a critical role in the future care of COPD, and trials such as the tezepelumab COURSE trial are central to understanding and shaping the treatment landscape," said Dr. Dave Singh, professor of respiratory pharmacology at the University of
COURSE Phase 2a analysis:
Table 1: Tezepelumab impact on COPD exacerbations versus placebo over 52 weeks
Reduction in | Annualized rate of exacerbations | |
Moderate or severe exacerbations | ||
Overall population (n=333) | 1.75 in tezepelumab group versus 2.11 in placebo group | |
BEC less than 150 cells/μL (n=137) | - | 2.04 in tezepelumab group versus 1.71 in placebo group |
BEC greater than or equal to 150 cells/μL (n-196) | 1.52 in tezepelumab group versus 2.40 in placebo group | |
BEC greater than or equal to 300 cells/μL (n=56) | 1.20 in tezepelumab group versus 2.24 in placebo group | |
Severe exacerbations | ||
Overall population (n=333) | 0.13 in tezepelumab group versus 0.25 in placebo group | |
Table 2: Tezepelumab impact on quality of life and lung function versus placebo over 52 weeks
Lung function as measured by pre- | Quality of life improvement as | |||||
Tezepelumab (n)/LS Mean | Placebo (n)/LS | LS mean | Tezepelumab (n)/LS Mean | Placebo (n)/LS | LS mean | |
BEC less | 73/-0.002 | 63/-0.053 | 0.051 (-0.012,0.114) | 69/-1.91 | 60/-0.30 | -1.62 (-6.69, |
BEC greater | 90/0.049 | 103/-0.014 | 0.063 (0.009, 0.116) | 88/-7.08 | 96/-2.85 | -4.23 (-8.51, |
BEC greater | 24/0.160 | 31/0.013 | 0.146 (0.044, 0.248) | 22/-10.22 | 27/-0.68 | -9.53 (-18.11, |
About the COURSE Phase 2a Trial
COURSE was a Phase 2a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe COPD receiving triple inhaled maintenance therapy, and having had two or more documented COPD exacerbations in the 12 months prior to Visit 1. A total of 337 patients were randomized globally, with patients stratified by region and prior number of exacerbations (two vs. three or more). Patients received tezepelumab 420 mg or placebo administered via subcutaneous injection at the trial site every four weeks over a 52-week treatment period. The trial included a post-treatment follow-up period of 12 weeks.
About Chronic Obstructive Pulmonary Disease (COPD)
COPD refers to a group of lung diseases, including chronic bronchitis and emphysema, that cause airflow blockage and breathing-related problems. COPD is a major public health threat that affects an estimated 391 million people around the world, with global costs connected to the disease expected to rise to US
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 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. TSLP 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. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. 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.
Beyond severe asthma, TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis (EoE). In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.
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, Amgen and AstraZeneca will jointly commercialize TEZSPIRE in North America. Amgen will record product sales in the U.S., with AstraZeneca recording its share of U.S. profits as Collaboration Revenue. Outside of the U.S., AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.
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 ≥
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 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.
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FAQ
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