ESMO: Padcev/Keytruda Combo Edges Closer To First-Line Bladder Cancer Filing

Big Boost For Seagen

Full data presented at ESMO from a closely watched trial of Seagen/Astellas’s Padcev and Merck & Co’s Keytruda should support regulatory approval of the combination in cisplatin-ineligible first-line metastatic urothelial cancer patients but concerns over duration of treatment remain.

First-line approval is the target for Padcev/Keytruda combo • Source: Shutterstock

The chances of the much-touted combination of Seagen Inc./Astellas Pharma, Inc.'s Padcev and Merck & Co., Inc.'s Keytruda getting approval in first-line urothelial cancer would appear to have improved on the back of more positive data presented at the European Society for Medical Oncology conference in Paris.

Cohort K of the Phase Ib/II EV-103/KEYNOTE-869 trial compared a combination of the antibody-drug conjugate Padcev (enfortumab vedotin) and 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