Novartis provides update on Phase III GCAptAIN study of Cosentyx® in giant cell arteritis (GCA)

Novartis today announced top-line results from the Phase III GCAptAIN study evaluating Cosentyx® (secukinumab) in adults with newly diagnosed or relapsing giant cell arteritis (GCA).

About the study

• In the study, Cosentyx was evaluated in combination with a 26-week steroid taper and compared to placebo plus a 52-week steroid taper.
• Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo.
• While the secondary outcomes did not show statistical superiority, Cosentyx showed numerically better outcomes compared to placebo for cumulative steroid dose and steroid-related toxicity.
• Safety in GCA was consistent with the known safety profile of Cosentyx1, which is supported by robust evidence and 10 years of real-world data across its approved indications.

Words from Shreeram Aradhye: CMO, Novartis

"While the Phase III results of GCAptAIN did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “We are grateful to the patients, investigators, and teams who made this study possible and will continue focusing on addressing areas of unmet medical need.”

Novartis will complete a full evaluation of the GCAptAIN data and share the results at a later date.

About GCAptAIN trial

• The GCAptAIN trial (NCT04930094) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with giant cell arteritis (GCA). 
• Patients were randomized into three treatment arms: Cosentyx 300 mg, Cosentyx 150 mg, or placebo, all in combination with a glucocorticoid (GC) taper regimen.
• The primary endpoint of the trial is to assess whether secukinumab 300 mg s.c. plus a 26-week GC taper is superior to placebo plus a 52-week GC taper in achieving sustained remission at Week 52 and the first secondary endpoint is the cumulative GC dose through Week 528.

About Cosentyx (secukinumab)

• Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases.
• It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS)9-11, as well as in pediatric patients with PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA)12,13. 
• Cosentyx is supported by robust evidence and 10 years of real-world data demonstrating its long-term safety and sustained efficacy2-7. 
• Since its launch in 2015, it has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries2.

About giant cell arteritis (GCA) 

• Giant cell arteritis (GCA) is the most common form of systemic vasculitis, primarily affecting people over 50 years of age14-16. 
• Because of its potential to cause irreversible vision loss and life-threatening aortic aneurysms, GCA is considered a medical emergency requiring prompt recognition and treatment17-19. 
• Beyond its physical complications, GCA significantly impairs quality of life, contributing to fatigue, cognitive difficulties, and reduced independence20-22. 

Disclaimer

• This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.
• Forward-looking statements can generally be identified by words such as:
  -“potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms.
• These statements may also be identified by express or implied discussions regarding: Potential marketing approvals, new indications or labeling for investigational or approved products.

Potential future revenues from such products.

• Caution: Do not place undue reliance on these statements.
• Such forward-looking statements are based on current beliefs and expectations regarding future events.
• They are subject to significant known and unknown risks and uncertainties.

Actual results may differ materially if:

• One or more risks or uncertainties materialize.
• Underlying assumptions prove incorrect.
• No guarantee that:
  -Investigational or approved products will be submitted or approved for sale or additional indications.
  -Products will be commercially successful in the future.
• Expectations could be affected by factors such as:
  -Uncertainties in research and development, including clinical trial results and additional data analysis.
  - Regulatory actions or delays.
  - Government regulations in general.
  - Global trends in healthcare cost containment and pricing pressures.
  - Need for increased pricing transparency.
  - Ability to obtain or maintain proprietary intellectual property protection.
  - Prescribing preferences of physicians and patients.
  - General political, economic, and business conditions.
  - Effects of and responses to pandemic diseases.
  - Safety, quality, data integrity, or manufacturing issues.
  - Data security and privacy breaches or IT system disruptions.
• Other risks are detailed in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission.
• Novartis does not undertake any obligation to update forward-looking statements in this press release due to new information, future events, or otherwise.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

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