Roche/Chugai’s Enspryng Not Good Enough In Phase III Myasthenia Gravis Study

Three Phase III Trials Ongoing In Three Other Indications

 
• By Mandy Jackson
  
Generate a summary of this article
Listen to this article
Beta

Many companies have late-stage myasthenia gravis programs in Phase III, but argenx and its Vyvgart competitors won a reprieve with the failure of IL-6 inhibitor Enspryng (satralizumab).

Concept of Myasthenia Gravis written on sticky notes isolated on Wooden Table.
The myasthenia gravis pharma market is growing despite some setbacks • Source: Shutterstock

Roche Holding AG subsidiary Chugai Pharmaceutical Co., Ltd.’s IL-6 receptor inhibitor Enspryng (satralizumab) achieved statistical significance on the primary endpoint in the Phase III LUMINESCE clinical trial in generalized myasthenia gravis (gMG), the firm announced 21 March, but the results did not meet the companies’ expectations on the degree of benefit versus placebo. The failure gives gMG market leader Vyvgart (efgartigimod alfa) from argenx N.V. more breathing room ahead of other competitors’ expected Phase III readouts in the disease.

Key Takeaways

  • Roche subsidiary Chugai said Enspryng did not meet the companies’ expectations for the drug in generalized myasthenia gravis (gMG) despite achieving statistical significance in a Phase III study.

Argenx, whose drug achieved blockbuster status in 2023 with $1.2bn in sales, gained 11.2% on the Enspryng news to close...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By Xu Hu

    Chinese firm Sciwind has revealed additional Phase III findings for its promising once-weekly GLP-1 agonist ecnoglutide, just one asset in a burgeoning Chinese sector that could see the emergence of new rivals to current global leaders in obesity and diabetes.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

     
    • By Xu Hu

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

  • Sponsored By:

    Nancy Tests SPARC-931-part

    The article discusses the impact of upcoming patent expirations in oncology biologics on biosimilar developers, highlighting the opportunities in Antibody-Drug Conjugates (ADCs) and Bispecific Antibodies (BsAbs). It explores the challenges posed by the structural complexities of these biologics, necessitating new bioanalytical tools and manufacturing processes. The evolving regulatory landscape, with contributions from EMA, FDA, and WHO, offers flexible pathways but also presents challenges. The article underscores the potential for biosimilars to generate significant cost savings and enhance patient access to cancer treatments over the next decade.

  • Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

    Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.

More from R&D