Amgen and AstraZeneca’s Tezspire achieves key milestone in Phase 3 nasal polyps trial

Amgen and AstraZeneca have revealed promising results from the Phase 3 Waypoint trial, demonstrating that Tezspire (tezepelumab-ekko) delivers significant and sustained relief for patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). The findings, published in the New England Journal of Medicine and presented at the AAAAI/WAO Joint Congress, indicate that the biologic treatment reduces nasal polyp size, alleviates congestion, and drastically cuts the need for surgery and systemic corticosteroids.

With CRSwNP affecting a large portion of the population, often leading to repeated surgeries and long-term corticosteroid use, the latest data from the Waypoint trial suggest Tezspire could emerge as a game-changing treatment option.

What Did the Waypoint Trial Reveal About Tezspire’s Effectiveness?

The Waypoint trial was designed as a randomized, double-blind, placebo-controlled study assessing Tezspire’s efficacy in adults with severe CRSwNP. The study included 408 participants, who received either Tezspire or a placebo through subcutaneous injection over a 52-week period. The trial measured nasal polyp size, congestion levels, and the necessity of surgery or systemic corticosteroids.

Results demonstrated that Tezspire achieved a statistically significant reduction in nasal polyp severity, as measured by the Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS). Patients receiving Tezspire experienced a 98% reduction in the need for nasal polyp surgery and an 88% reduction in systemic corticosteroid use compared to placebo. Additionally, noticeable improvements in nasal polyp size were observed as early as week four, while congestion relief was reported by week two.

These findings highlight Tezspire’s potential to address a critical gap in CRSwNP treatment, offering a non-surgical alternative for patients with persistent nasal polyps and severe congestion.

How Does Tezspire Work in Treating Nasal Polyps?

Tezspire is a first-in-class monoclonal antibody that specifically targets thymic stromal lymphopoietin (TSLP), a key inflammatory cytokine linked to various airway diseases, including severe asthma and CRSwNP. Unlike traditional treatments that focus on a single inflammatory pathway, Tezspire blocks multiple inflammatory cascades, addressing eosinophilic, allergic, and non-allergic airway inflammation.

CRSwNP is driven by chronic inflammation of the nasal passages, often resulting in obstructive nasal polyps, loss of smell, and severe congestion. Many existing therapies target interleukin pathways, which only benefit a subset of patients with specific inflammatory markers. Tezspire’s broader mechanism of action enables it to treat a wider population of patients, including those who may not respond to currently available biologics.

By blocking TSLP, Tezspire prevents the release of pro-inflammatory cytokines, which trigger nasal polyp formation and persistent airway inflammation. This not only reduces polyp size and congestion but also lowers the likelihood of relapse, potentially eliminating the need for repeated surgeries.

What Does the Data Mean for Patients and Physicians?

The Waypoint trial findings underscore Tezspire’s potential as a long-term solution for patients struggling with chronic nasal polyps. Current treatment options, including nasal corticosteroids, oral steroids, and surgery, often fail to provide sustained relief. Many patients require multiple surgical procedures, with polyps frequently returning within months.

Experts analyzing the results believe Tezspire could redefine treatment protocols by offering a biologic alternative to surgery. The ability to reduce reliance on corticosteroids is particularly significant, as long-term steroid use is linked to serious side effects, including osteoporosis, weight gain, and cardiovascular risks.

For physicians, these findings highlight the importance of addressing inflammatory pathways earlier in the treatment process. By incorporating biologic therapies like Tezspire into standard CRSwNP care, healthcare providers may be able to reduce the disease burden and improve long-term outcomes for patients.

What Is Tezspire’s Current Regulatory and Commercial Status?

Tezspire is already approved for severe asthma in over 50 countries, including the United States, Europe, and Japan. It is available in a pre-filled pen and auto-injector format, making self-administration accessible for patients.

Following the Waypoint trial results, Amgen and AstraZeneca have submitted regulatory filings to expand Tezspire’s label to include CRSwNP. If approved, Tezspire could become a leading treatment option for nasal polyps, providing an alternative to invasive surgeries. Regulatory reviews are currently underway in multiple regions, and an approval decision is expected in the near future.

Beyond CRSwNP, Tezspire is being explored for chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE). In July 2024, the U.S. FDA granted Breakthrough Therapy Designation for Tezspire in treating moderate to severe COPD in patients with an eosinophilic phenotype, further broadening its potential market reach.

How Safe Is Tezspire for Long-Term Use?

In the Waypoint trial, Tezspire’s safety profile remained consistent with its previously approved use in severe asthma. The most frequently reported side effects included nasopharyngitis, upper respiratory tract infections, and COVID-19 infections. No new safety concerns emerged, reinforcing Tezspire’s potential as a well-tolerated treatment for nasal polyps.

What’s Next for Tezspire in the Biologic Treatment Landscape?

As biologic therapies gain traction in respiratory and inflammatory diseases, Tezspire’s success in the Waypoint trial positions it as a strong contender in the growing biologics market. With its unique mechanism of action and broad applicability, Tezspire could establish itself as a cornerstone treatment for chronic inflammatory airway diseases.

The collaboration between Amgen and AstraZeneca will continue to play a crucial role in Tezspire’s commercial success. Under their agreement, AstraZeneca leads global commercialization, while Amgen handles manufacturing and recognizes U.S. sales revenue. As regulatory decisions approach, industry analysts will be watching closely to assess how Tezspire’s expanded approval could impact market competition and revenue growth for both companies.

With CRSwNP affecting millions worldwide, the potential for Tezspire to reduce the need for surgery, alleviate congestion, and improve patient quality of life is a significant development in the field of respiratory medicine. As the regulatory process unfolds, the pharmaceutical industry will be closely monitoring the next phase of Tezspire’s journey.