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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:
    20h
    CLeAR: Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Virginia Commonwealth University | Initiation date: Feb 2026 --> Jul 2026
    Trial initiation date
    |
    CD4 (CD4 Molecule)
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    1d
    First-Line Cemiplimab for Locally Advanced NSCLC: Updated Subgroup Analyses From the EMPOWER-Lung 1 and EMPOWER-Lung 3 Trials. (PubMed, JTO Clin Res Rep)
    Favorable patient-reported outcomes were observed with cemiplimab monotherapy than chemotherapy; no significant patient-reported outcomes favoring chemotherapy were observed in either study. This subgroup analysis supports the clinical benefit of 1L cemiplimab as monotherapy or combined with chemotherapy in patients with unresectable locally advanced NSCLC (not candidates for definitive chemoradiotherapy).
    Journal • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc)
    1d
    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 | Trial completion date: Jul 2027 --> Jul 2031 | Trial primary completion date: Jul 2027 --> Jul 2031
    Trial completion date • Trial primary completion date
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    3d
    A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=120, Recruiting, Regeneron Pharmaceuticals | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    8d
    ARCH: A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy (clinicaltrials.gov)
    P3, N=390, Recruiting, ETOP IBCSG Partners Foundation
    Trial initiation date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc)
    8d
    Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer (clinicaltrials.gov)
    P2, N=44, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | N=33 --> 44
    Enrollment change • MSI-H
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    9d
    Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=108, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Trial completion date: Oct 2033 --> Dec 2030 | Initiation date: Feb 2026 --> Nov 2026 | Trial primary completion date: Oct 2033 --> Dec 2030
    Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date
    |
    cisplatin • carboplatin • paclitaxel • Libtayo (cemiplimab-rwlc)
    13d
    Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P1/2, N=100, Active, not recruiting, Servier Bio-Innovation LLC | N=74 --> 100
    Enrollment change • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Libtayo (cemiplimab-rwlc) • S95018 • S95029
    13d
    A Multi-Center Single-Arm Phase 2 Trial Of Zanzalintinib In Combination With Cemiplimab In BRAF Wild-Type Anaplastic Thyroid Cancer: The ZEPHYR Trial (clinicaltrials.gov)
    P2, N=12, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • BRAF V600 • BRAF wild-type
    |
    Libtayo (cemiplimab-rwlc) • zanzalintinib (XL092)
    13d
    Composite patient-reported outcomes and risk prediction for overall survival in advanced non-small cell lung cancer with first-line cemiplimab. (PubMed, Front Oncol)
    In patients with advanced NSCLC receiving first-line cemiplimab-based therapy, composite PROs consisting of one functioning and one symptom scale had greater prognostic value than single PRO scales. Further development and analysis of composite PROs for clinical trials is warranted.
    Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    Libtayo (cemiplimab-rwlc)
    14d
    Progression patterns and clinical outcomes in patients with cutaneous squamous-cell carcinoma following anti-PD-1 therapy failure. (PubMed, ESMO Open)
    In this cohort of patients with CSCC, distant metastatic and locoregional progression were the predominant patterns following anti-PD-1 failure, with lower TMB linked to primary resistance. Prior chemotherapy was associated with poorer OS. Select patients benefited from subsequent treatments, including cetuximab and local therapy.
    Clinical data • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden) • EFS (Embryonal Fyn-Associated Substrate)
    |
    TMB-L
    |
    Erbitux (cetuximab) • Libtayo (cemiplimab-rwlc)
    14d
    RAD-IO: Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC (clinicaltrials.gov)
    P2, N=54, Active, not recruiting, The Netherlands Cancer Institute | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jun 2026
    Enrollment closed • Trial completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 negative
    |
    Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc)