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    DRUG:

    Libtayo (cemiplimab-rwlc)

    i
    Other names: REGN2810, SAR439684, REGN 2810, SAR 39684, REGN-2810, SAR-439684
    Company:
    GENESIS Pharma, Medison, Regeneron
    Drug class:
    PD1 inhibitor
    Related drugs:
    2d
    A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment (clinicaltrials.gov)
    P2, N=68, Not yet recruiting, University of Chicago | Initiation date: Jan 2026 --> Dec 2026
    Trial initiation date • Minimal residual disease
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx • NavDx®
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3d
    GRWD5769-ST-01: A Modular, Multi-part, Multi-arm, Open-label, Phase I/II Study to Evaluate the Safety and Tolerability of GRWD5769 Alone and in Combination with Anticancer Treatments in Patients with Solid Malignancies (2023-504845-30-00)
    P1/2, N=130, Recruiting, Grey Wolf Therapeutics Limited | N=65 --> 130
    Enrollment change
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H
    |
    Libtayo (cemiplimab-rwlc) • GRWD5769
    3d
    Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 (clinicaltrials.gov)
    P2, N=33, Not yet recruiting, Henry Ford Health System
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Libtayo (cemiplimab-rwlc)
    4d
    LAG-BOOST: Cemiplimab or Cemiplimab and Fianlimab After Stereotactic Body Radiotherapy in Clear Cell Renal Cell Carcinoma (clinicaltrials.gov)
    P2, N=72, Recruiting, University of Oklahoma | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    8d
    A Treatment Decision Model for Cutaneous Squamous Cell Carcinoma Based on Bayesian Networks. (PubMed, Cancers (Basel))
    Our results suggest that BNs are a valuable tool for representing complex clinical decision-making processes.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc)
    9d
    GAP Cemi: Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC) (clinicaltrials.gov)
    P2, N=20, Recruiting, Columbia University
    New P2 trial
    |
    CD4 (CD4 Molecule)
    |
    cisplatin • gemcitabine • albumin-bound paclitaxel • Libtayo (cemiplimab-rwlc)
    10d
    Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer (clinicaltrials.gov)
    P2, N=48, Recruiting, National Cancer Institute (NCI) | Initiation date: Jul 2026 --> Feb 2026
    Trial initiation date
    |
    Cabometyx (cabozantinib tablet) • Libtayo (cemiplimab-rwlc)
    11d
    A Randomized Trial of Fianlimab and Cemiplimab +/- Ipilimumab or Ipilimumab Plus Nivolumab in First-line Advanced Renal Cell Carcinoma (RCC) (clinicaltrials.gov)
    P2, N=120, Recruiting, Brian Rini | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    14d
    Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=30, Not yet recruiting, National Cancer Institute (NCI)
    New P1 trial • Tumor mutational burden • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • MGMT (6-O-methylguanine-DNA methyltransferase) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    IDH wild-type • IDH1 R132
    |
    Libtayo (cemiplimab-rwlc) • Actimab-A (lintuzumab-Ac225) • Zamyl (lintuzumab)
    15d
    Efficacy of immune checkpoint inhibitors in the first line therapy of non-squamous non-small cell lung cancer: a systematic review and network meta-analysis. (PubMed, Crit Rev Oncol Hematol)
    For advanced nsNSCLC patients, irrespective of PD-L1 expression, prolgolimab, pembrolizumab or cemiplimab, each combined with chemotherapy, are most efficacious by OS; nivolumab or atezolizumab combined with bevacizumab and chemotherapy demonstrate the highest PFS. PD-L1 expression does not modify the effect of examined immunotherapy options on OS, though the opposite is true for PFS.
    Clinical • Retrospective data • Review • Journal • Checkpoint inhibition • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression • PD-L1 negative
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Tecentriq (atezolizumab) • Libtayo (cemiplimab-rwlc) • Forteca (prolgolimab)
    16d
    Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery (clinicaltrials.gov)
    P2, N=70, Recruiting, Thomas Jefferson University | N=35 --> 70
    Enrollment change
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    17d
    CECYDE: A Multicenter Open-label Phase II Study of Cemiplimab Plus Chemotherapy, Selected on the Basis of Baseline Cytidine Deaminase Activity, in Advanced Squamous Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=108, Not yet recruiting, Gruppo Oncologico Italiano di Ricerca Clinica
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • carboplatin • gemcitabine • paclitaxel • Libtayo (cemiplimab-rwlc)