^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Jemperli (dostarlimab-gxly)

    i
    Other names: TSR-042, ANB011, GSK4057190, ANB 011, WBP-285, TSR 042, TSR042, ANB-011, GSK-4057190, GSK 4057190, WBP 285, WBP285
    Company:
    AnaptysBio, GSK, Sagard Healthcare
    Drug class:
    PD1 inhibitor
    Related drugs:
    5d
    TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, University of Hawaii | Trial primary completion date: Oct 2025 --> Mar 2026
    Trial primary completion date
    |
    Jemperli (dostarlimab-gxly) • cobolimab (TSR-022)
    6d
    Phase II randomized trial of XELOX plus DoSTARlimab versus XELOX alone as Consolidation Treatmentafter Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC)Patients IMMUNOSTAR Trial - GOIRC-02-2024 (2024-519798-20-00)
    P1/2, N=270, Recruiting, G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica | Not yet recruiting --> Recruiting
    Enrollment open • pMMR
    |
    MSI (Microsatellite instability)
    |
    capecitabine • oxaliplatin • Jemperli (dostarlimab-gxly)
    7d
    STARKAP: Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, Imperial College London | Recruiting --> Active, not recruiting | Trial completion date: Apr 2026 --> Dec 2026 | Trial primary completion date: Apr 2026 --> Jul 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    CD4 (CD4 Molecule)
    |
    Jemperli (dostarlimab-gxly)
    15d
    First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=152, Active, not recruiting, GlaxoSmithKline | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Jemperli (dostarlimab-gxly) • belrestotug (EOS-448) • nelistotug (GSK6097608) • risvutatug rezetecan (GSK5764227)
    30d
    DOVIPA, a Study Evaluating Efficacy and Safety of DOstarlimab and VItamin D3 with MFOLFIRINOX in PAncreatic Cancer (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Hopital Foch | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    5-fluorouracil • oxaliplatin • irinotecan • Jemperli (dostarlimab-gxly) • leucovorin calcium
    1m
    Real-World Use of Dostarlimab Plus Chemotherapy in Advanced or Recurrent dMMR Endometrial Cancer: A Nationwide Cohort Study in France. (PubMed, BioDrugs)
    This first real-world study of dostarlimab plus chemotherapy in advanced or recurrent endometrial cancer involved an older, more comorbid, and less selected population with more advanced disease than in RUBY. Survival outcomes were less favorable, but the safety profile was comparable.
    Journal • Real-world evidence • dMMR
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Jemperli (dostarlimab-gxly)
    2ms
    Phase II randomized trial of XELOX plus DoSTARlimab versus XELOX alone as Consolidation Treatmentafter Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC)Patients IMMUNOSTAR Trial - GOIRC-02-2024 (2024-519798-20-00)
    P1/2, N=270, Not yet recruiting, G.O.I.R.C. Gruppo Oncologico Italiano Di Ricerca Clinica
    New P1/2 trial • pMMR
    |
    MSI (Microsatellite instability)
    |
    capecitabine • oxaliplatin • Jemperli (dostarlimab-gxly)
    2ms
    The Influence of Molecular Factors on the Effectiveness of New Therapies in Endometrial Cancer-Latest Evidence and Clinical Trials. (PubMed, Cancers (Basel))
    This classification (refined in ProMisE and TransPORTEC) enables precise treatment: immunotherapy (pembrolizumab, dostarlimab) works excellently in dMMR/MSI-H tumors, PI3K/AKT/mTOR inhibitors and trastuzumab deruxtecan in selected molecular subtypes, and hormone therapy in ER-positive tumors. Integrating the molecular profile with FIGO allows for truly personalized treatment, although MMRp/MSS tumors remain a challenge. The future lies in multi-omics, new biomarkers, and combination therapies.
    Review • Journal • MSi-H Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    ER (Estrogen receptor) • MSI (Microsatellite instability)
    |
    ER positive • MSI-H/dMMR
    |
    Keytruda (pembrolizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Jemperli (dostarlimab-gxly)
    2ms
    BeeHive: A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, University Health Network, Toronto
    New P2 trial • IO biomarker
    |
    Jemperli (dostarlimab-gxly) • risvutatug rezetecan (GSK5764227)
    2ms
    Superhero: Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR/MSS Resectable Colon Cancer (clinicaltrials.gov)
    P2, N=10, Recruiting, Universitaire Ziekenhuizen KU Leuven | Not yet recruiting --> Recruiting
    Enrollment open • pMMR
    |
    Jemperli (dostarlimab-gxly)
    2ms
    Niraparib in Combination With Dostarlimab in Patients With Recurrent or Progressive Cervix Cancer (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, University of Oklahoma | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date
    |
    Zejula (niraparib) • Jemperli (dostarlimab-gxly)
    2ms
    Real-World Evidence for 10 Oncology Drugs Approved in the last 5 years: A Comprehensive Narrative Synthesis. (PubMed, Crit Rev Oncol Hematol)
    RWE confirms the effectiveness and safety of multiple recently approved oncology drugs reinforcing the external validity of RCTs.
    Review • Journal • HEOR • Real-world evidence • MSi-H Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • MSI (Microsatellite instability)
    |
    HER-2 positive • MSI-H/dMMR • HER-2 negative • ESR1 mutation
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Lumakras (sotorasib) • Retevmo (selpercatinib) • Jemperli (dostarlimab-gxly) • Krazati (adagrasib) • Tepmetko (tepotinib) • Tabrecta (capmatinib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • Orserdu (elacestrant)