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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:
    1d
    NeoMatryx: Neoadjuvant Merkel Cell Carcinoma Therapy (Tx) With the PD-1 Inhibitor Cemiplimab (clinicaltrials.gov)
    P2, N=135, Not yet recruiting, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    New P2 trial
    |
    Libtayo (cemiplimab-rwlc)
    4d
    COMBINE-EGFR-1: A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers (clinicaltrials.gov)
    P1/2, N=933, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Dec 2026 --> Apr 2027
    Trial completion date
    |
    Avastin (bevacizumab) • Libtayo (cemiplimab-rwlc) • Lonsurf (trifluridine/tipiracil)
    4d
    CLIO-1: A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies (clinicaltrials.gov)
    P1, N=105, Active, not recruiting, Regeneron Pharmaceuticals | Trial completion date: Dec 2025 --> May 2026 | Trial primary completion date: Dec 2025 --> May 2026
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • Ordspono (odronextamab)
    6d
    French recommendations for clinical practice, Nice-Saint-Paul de Vence 2024-2025: Management of advanced cervical cancer (PubMed, Bull Cancer)
    Since 2022, immunotherapy is part of standard therapeutic strategy with pembrolizumab on the one hand, associated with chemotherapy and bevacizumab in patients with PD-L1 positive tumors (CPS≥1), and cemiplimab on the other hand, in patients who did not receive prior immunotherapy and progress after first line regardless of PD-L1 expression. Whenever possible, molecular screening and determination of HER2 status may allow orienting patients to clinical trials. Indeed, inclusion in investigational studies must be systematically considered and early supportive care is always recommended.
    Clinical guideline • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • Libtayo (cemiplimab-rwlc)
    8d
    Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=11, Recruiting, City of Hope Medical Center | Initiation date: Dec 2025 --> Apr 2026
    Trial initiation date • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • CD4 (CD4 Molecule)
    |
    Libtayo (cemiplimab-rwlc) • SIR-Spheres (yttrium-90 microspheres)
    9d
    Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Feb 2026 --> Oct 2026
    Enrollment open • Trial initiation date
    |
    cisplatin • carboplatin • paclitaxel • Libtayo (cemiplimab-rwlc)
    9d
    Why Cemiplimab? Defining a Unique Therapeutic Niche in First-Line Non-Small-Cell Lung Cancer with Ultra-High PD-L1 Expression and Squamous Histology. (PubMed, Cancers (Basel))
    The landscape of first-line treatment for metastatic non-small cell lung cancer (NSCLC) without actionable driver mutations is rapidly evolving, currently dominated by pembrolizumab-based regimens. Secondly, cemiplimab displays consistent, robust efficacy in challenging-to-treat squamous histology, both as monotherapy for patients with high PD-L1 expression and in combination with chemotherapy for patients with PD-L1 < 50%. In conclusion, cemiplimab establishes a unique therapeutic niche for patients with squamous histology and ultra-high PD-L1 expression, likely driven by its distinct structural stability and reduced immunogenicity.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)
    9d
    NCI-2018-01313: Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery (clinicaltrials.gov)
    P2, N=44, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc)
    10d
    CLeAR: Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Virginia Commonwealth University
    New P1 trial
    |
    CD4 (CD4 Molecule)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    13d
    PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Duke University | Trial completion date: Jan 2027 --> Mar 2026 | Trial primary completion date: Jan 2026 --> Sep 2025
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    MET exon 14 mutation
    |
    Libtayo (cemiplimab-rwlc) • Praluent (alirocumab)
    14d
    HARMONY LUNG-2: A Trial to Learn How the Combination of Fianlimab With Cemiplimab and Chemotherapy Works Compared With Cemiplimab and Chemotherapy for Treating Adult Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2/3, N=950, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    15d
    HARMONY LUNG-1: A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P2/3, N=850, Active, not recruiting, Regeneron Pharmaceuticals | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)