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
    • Marketing & Promotions
    • The Antibody Society’s Committees
      • Meetings Committee
      • AIRR Community Working Groups & Sub-Committees
    • Sponsors & Partners
  • Society meetings
    • Computational Antibody Discovery: State of the Art
      • Computational Antibody Discovery Symposium Participants
    • 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) 2024
      • 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 10 – 12 June, 2025 | Congress Center, Basel Switzerland.
      • Scientific Advisors, Antibody Engineering & Therapeutics Europe
    • FOCIS Symposia
  • AIRR Community
    • AIRR Community News
    • AIRR Community Newsletter
    • AIRR Community Seminar Series
    • AIRR Community Meetings
      • Zooming into the Community III
      • AIRR Community Meeting VII – Learnings and Perspectives
      • AIRR Community Special Event 2023  – Zooming in to the Community II
      • 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
    • On AIRR – An AIRR Community Podcast
    • AIRR Data Commons
    • AIRR-C Germline Database Resources
    • AIRR Community Publications
    • 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
      • Strategic Planning Sub-Committee
    • AIRR Community Webinar Series
    • AIRR Community Calendar
    • AIRR Community Resources
  • Members only
    • Login
    • Note to members
    • Member discount codes
    • 2025 Calendar of Events
    • James S. Huston Antibody Science Talent Award
      • 2024 James S. Huston Antibody Science Talent Award Recipient
      • 2023 James S. Huston Antibody Science Talent Award Recipient
      • 2022 James S. Huston Antibody Science Talent Award Recipient
      • 2021 James S. Huston Antibody Science Talent Award Recipient
      • 2020 James S. Huston Antibody Science Talent Award Recipient
      • Huston Award submission guidelines
    • Research Competitions
      • Research Competition Winners
    • Science Writing Competition
      • Science Writing Competition Winners
    • Imaging Competition
      • Imaging Calendar Competition winners
        • The Antibody Society 2025 Calendar
        • The Antibody Society 2024 Calendar
    • Antibodies in early-stage studies
    • Presentations
  • Upcoming meetings in 2025
  • Web Resources
    • Society Publications
    • Antibody News
    • Antibody News Podcast
    • 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 in 2025
    • The Antibody Series Lectures
    • Antibody Discovery & Development
    • Adaptive Immune Receptor Repertoires
    • Antibodies to Watch
    • Commercializing Antibody Therapeutics
    • Antibody Validation
      • 4th International Antibody Validation Meeting, Sep 2023
    • Snakebite antivenoms: Global challenges and progress toward recombinant antibody therapeutics
You are here: Home / Antibody therapeutic / Dostarlimab approved by FDA for endometrial cancer

Dostarlimab approved by FDA for endometrial cancer

April 22, 2021 by The Antibody Society

On April 22, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers are deficient in their ability to repair DNA inside the cell, as determined by an FDA-approved test. FDA granted dostarlimab Priority Review and Breakthrough Therapy designations for this indication. Dostarlimab (TS-042, GSK4057190A) is an anti-PD-1 humanized IgG4k antibody generated by Anaptysbio under partnership with Tesaro, which was acquired by GlaxoSmithKline in 2019.

Interim analyses of data for patients with mismatch repair (MMR)-deficient endometrial cancer with recurrent or advanced disease that progressed on a platinum doublet regimen enrolled in the Phase 1 GARNET study (NCT02715284) were reported at the European Society for Medical Oncology (ESMO) Virtual Congress in September 2020. Patients received 500 mg of dostarlimab every 3 weeks for the first 4 cycles, then 1,000 mg every 6 weeks until disease progression or discontinuation. The primary endpoints included confirmed objective response rate (ORR) and duration of response (DOR). The ORR was 44.7% in patients with deficient mismatch repair (dMMR) disease and 13.4% in those with MMR-proficient (MMRp) disease. In the dMMR cohort (n = 103), 11 complete responses, and 35 partial responses were observed. Thirteen patients achieved stable disease, while 39 patients experienced disease progression. In the MMRp cohort (n = 142), 3 patients had complete responses, 16 had partial responses, 31 achieved stable disease, and 77 patients experienced progressive disease. At the time of data cutoff, with a median follow up of 11.2 months, the median DOR had not been reached.

Dostarlimab is also being evaluated as a treatment for various types of cancer in early-stage clinical studies, as well as two Phase 3 studies, RUBY and FIRST. The RUBY study (NCT03981796) is evaluating dostarlimab plus carboplatin-paclitaxel versus placebo plus carboplatin-paclitaxel in patients with recurrent or primary advanced endometrial cancer. The primary outcome measure is the progression-free survival (PFS) assessed by an investigator, and the primary completion date is July 2021. The FIRST study (NCT03602859) is a comparison of platinum-based therapy with dostarlimab and niraparib versus standard of care platinum-based therapy as first-line treatment of Stage III or IV non-mucinous epithelial ovarian cancer. The primary outcome measure is the PFS and the primary completion date is January 2023.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Filed Under: Antibody therapeutic, Food and Drug Administration Tagged With: antibody therapeutics, dostarlimab, Food and Drug Administration

Share this post

  • LinkedIn

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

  • Zooming into the Community III Starts Tomorrow! May 20, 2025
  • Exciting news – The AIRR Community is turning 10! 🎂 May 8, 2025
  • The Antibody Society (TAbS): Win a FREE Attendance Pass to AET Basel & Present A Poster: Call For Abstracts! March 26, 2025

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