Lack Of Efficacy, Not Safety, Dooms Merck KGaA’s BTK Inhibitor

Evobrutinib flunked its Phase III multiple sclerosis program not because of its known toxicity, but because it didn’t work.  

A man shows a thumb down. Gesture of disapproval and rejection. Bad assessment, harsh criticism, failure and defeat. Refusal to pass and cooperation. Bureaucratic obstacles. Contempt and condemnation

Merck KGaA, its investors and sellside analysts alike found themselves casting around for excuses today after the total failure of evobrutinib in its twin pivotal multiple sclerosis trials. The finding is particularly ironic given that most Merck followers were concerned about evobrutinib’s safety, not its efficacy.

Key Takeaways

  • The failure of evobritinib in multiple sclerosis removes a key growth driver for Merck KGaA

Thus the data clearly came as a shock, and Merck’s stock is trading down by 13% at €141.10 on the...

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.

More from Clinical Trials

  • Sciwind Eyes Differentiation For Ecnoglutide In Highly Competitive Arena

     
    • By 

    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 

    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