The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

  • LOG IN
  • BECOME A MEMBER
  • About
    • Mission & Activities
    • Directors and Officers
    • The Antibody Society’s Committees
      • AIRR Community Committee
      • Communication & Membership Committee
      • Meetings Committee
    • Sponsors & Partners
  • Society meetings
    • Harnessing Cytokines for Cancer Immunotherapy Symposium
    • Biopharmaceutical Informatics Symposium
    • Emerging Cancer Therapies Leveraging Gamma-Delta Effector T cells Symposium
    • Emerging Immunotherapeutics for Ovarian Cancer Symposium
    • AIRR Community Meetings
    • Antibody Engineering & Therapeutics (US) 2023
      • 2022 Antibody Engineering & Therapeutics
      • 2020 Antibody Engineering & Therapeutics
      • 2019 Antibody Engineering & Therapeutics
      • 2018 Antibody Engineering & Therapeutics
      • What is INN a Name?
        • INN issue updates
    • Antibody Engineering & Therapeutics Europe 2023
    • FOCIS Symposia
  • AIRR Community
    • AIRR News
    • AIRR Publications
    • AIRR Meetings
      • AIRR Community Meeting VI: “Exploring New Frontiers”
      • AIRR Community Meeting V: “Zooming in to the AIRR Community”
      • AIRR Community Meeting V Pre-Meetings
        • AIRR-seq in the Pandemic
        • AIRR-seq Biological Standards and Workflows
      • AIRR Community Special Event: “Response to COVID-19”
      • AIRR Community Meeting IV: “Bridging the Gaps”
      • AIRR Community Meeting III
        • Day 1
        • Day 2
        • Day 3
        • Day 4
      • AIRR Community Meeting II
      • AIRR Community Meeting I
    • AIRR Community Working Groups
      • Biological Resources Working Group
      • Common Repository Working Group
      • Diagnostics Working Group
      • Germline Database Working Group
      • Legal and Ethics Working Group
      • Software Working Group
      • Standards Working Group
    • AIRR Community Sub-committees
      • Communications Sub-committee
      • Executive Sub-committee
      • Inferred Allele Review Committee
      • Meetings Sub-committee
    • AIRR Data Commons
    • AIRR Community Calendar
    • AIRR Community Webinar Series
    • On AIRR – An AIRR Community Podcast
    • AIRR Community Resources
    • AIRR Community Service Prize 2022
  • Members only
    • Login
    • Note to members
    • James S. Huston Antibody Science Talent Award
      • 2021 James S. Huston Antibody Science Talent Award Recipient
      • 2020 James S. Huston Antibody Science Talent Award Recipient
      • JSH Award Criteria
    • Science Writing Competition
      • Science Writing Competition Winners
    • Imaging Competition
    • Research Competitions
      • Research Competition Winners
    • Member discount codes
    • Antibodies in early-stage studies
    • Presentations
  • Upcoming meetings
  • Web Resources
    • Society Publications
    • Antibody News
    • Antibody therapeutics approved or in regulatory review in the EU or US
      • Antibody therapeutics product data
    • Antibodies in late-stage clinical studies
    • Research Resources
    • Education Resources
  • Career Center
    • Career Shorts
  • Learning Center
    • Upcoming Webinars
    • Snakebite antivenoms: Global challenges and progress toward recombinant antibody therapeutics
    • Adaptive Immune Receptor Repertoires
    • Antibody Discovery & Development
    • Commercializing Antibody Therapeutics
    • Antibodies to Watch
    • Antibody Validation
  • COVID-19
    • Guide to “Coronavirus in the Crosshairs”
    • COVID-19 Biologics Tracker
    • Meeting Report: The Diagnostic Landscape for COVID-19
You are here: Home / Archives for tebentafusp

FDA approves KIMMTRAK® (tebentafusp-tebn) for unresectable or metastatic uveal melanoma

January 26, 2022 by Janice Reichert

On January 26, 2022, Immunocore Holdings plc announced the approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM). Tebentafusp (IMCgp100) is a bispecific fusion protein composed of: 1) a T cell receptor (TCR) recognizing a human leukocyte antigen (HLA)-A*02:01 complexed with a peptide derived from gp100 antigen expressed by melanoma cells, and 2) an antibody single-chain variable fragment that binds CD3 present on T cells. Developed by Immunocore, this molecule creates a bridge between tumor cells and immune cells, and thus facilitates tumor-cell killing by T cells. As the TCR domain recognizes a peptide presented on HLA-A*02:01, tebentafusp can only be used to treated patients expressing this HLA type. Tebentafusp has been granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA.

The marketing applications are based on a late-stage clinical trial (NCT03070392) that enrolled 378 patients with advanced uveal melanoma who were HLA-A*0201–positive. In the study, patients were randomized 2:1 to receive tebentafusp or investigator’s choice of therapy (either pembrolizumab, ipilimumab, or dacarbazine). Tebentafusp was administered at a dose of 20 micrograms on cycle 1 Day 1, then 30 micrograms on cycle 1 Day 8, then 68 micrograms on cycle 1 Day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity. The primary outcome measure is overall survival. As reported in September 2021, the OS Hazard Ratio in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). Moreover, the 1-year survival rate was 73% for patients in the experimental arm vs. 59% in the investigator’s choice arm.

The European Medicines Agency, the United Kingdom’s Medicines and Healthcare Regulatory Agency, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration have accepted the submission of Marketing Authorisation Applications for tebentafusp.

KIMMTRAK is the 1st antibody-based therapeutic granted a first approval for marketing in the EU or US in 2022. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

Filed Under: Antibody therapeutic, Food and Drug Administration Tagged With: approved antibodies, Food and Drug Administration, melanoma, tebentafusp

mabs

mabs

The Official Journal of The Antibody Society

Career Center

Our Career Center is a premier resource to connect highly qualified talent with matching career opportunities. Visit for details on over 800 jobs!

AIRR Community

AIRR Community

The Adaptive Immune Receptor Repertoire Community is a research-driven group organizing around the use of high-throughput sequencing technologies to study antibody/B-cell and T-cell receptor repertoires.

Recent Posts

  • The Antibody Society announces the election of new Directors and Officers January 26, 2023
  • AIRR Data Commons and iReceptor Science Gateway Start Major Collaboration with Type-1 Diabetes Researchers January 11, 2023
  • FDA approves Leqembi (lecanemab-irmb) for the treatment of Alzheimer’s disease January 6, 2023

Archives

Follow us online

  • Email
  • LinkedIn
  • Twitter
  • YouTube
  • Home
  • Privacy & Terms of Use
  • About
  • Directors and Officers
  • Advisors
  • Sponsors & Partners
  • Mission & Activities
  • Join the Society
  • Membership Levels
  • Members only
  • Login
  • Antibody therapeutics approved or in regulatory review in the EU or US
  • Meeting reports
  • Presentations
  • Contact

©2015 - scicomvisuals