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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:
    3d
    UC-IMM-2511/2512: METAREM / META-1 - METAREM :Immunotherapy Master Trial for Advanced Cancers / META-1: Immunotherapy without chemotherapy for advanced lung cancer patients with high PD-L1 Levels. (2025-522655-26-00)
    P1/2, N=55, Not yet recruiting, Unicancer
    New P1/2 trial
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK mutation
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    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)
    5d
    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 | Initiation date: Feb 2026 --> Jun 2026
    Trial initiation date
    |
    Libtayo (cemiplimab-rwlc)
    7d
    A Phase Ib Study to Evaluate the Safety and Preliminary Efficacy of IL6-receptor Antibody Sarilumab in Combination With antiPD1 Antibody Cemiplimab for Patients With Non-small Cell Lung Cancer. (clinicaltrials.gov)
    P1, N=56, Active, not recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jan 2026 --> Jan 2028
    Trial primary completion date
    |
    STK11 (Serine/threonine kinase 11)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Libtayo (cemiplimab-rwlc) • Kevzara (sarilumab)
    7d
    A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery (clinicaltrials.gov)
    P2, N=195, Recruiting, Regeneron Pharmaceuticals | Active, not recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    cisplatin • carboplatin • paclitaxel • pemetrexed • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    8d
    Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, University of California, Irvine
    New P2 trial
    |
    Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)
    8d
    LuCa-MERIT-1: Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=320, Recruiting, BioNTech SE | N=156 --> 320
    Enrollment change • First-in-human
    |
    ALK (Anaplastic lymphoma kinase) • LAG3 (Lymphocyte Activating 3) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ALK rearrangement • RET rearrangement
    |
    Tagrisso (osimertinib) • carboplatin • paclitaxel • docetaxel • Libtayo (cemiplimab-rwlc) • gotistobart (BNT316) • BNT116
    8d
    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: Mar 2026 --> Nov 2026
    Trial 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)
    9d
    Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cemiplimab (REGN2810), in Treating Refractory Microsatellite Stable Colorectal Cancer (clinicaltrials.gov)
    P1/2, N=86, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Mar 2026 --> Dec 2026
    Enrollment open • Trial initiation date
    |
    MSI (Microsatellite instability) • MYC (V-myc avian myelocytomatosis viral oncogene homolog) • FBXW7 (F-Box And WD Repeat Domain Containing 7)
    |
    Libtayo (cemiplimab-rwlc) • pidnarulex (CX-5461)
    9d
    Comparative pharmacovigilance signals for PD-1, PD-L1, CTLA-4, and LAG-3 immune checkpoint inhibitor-associated hemophagocytic lymphohistiocytosis in the FAERS database. (PubMed, J Oncol Pharm Pract)
    Among PD-1 inhibitors, pembrolizumab exhibited the highest burden (n = 120; ROR 9.51, 95% CI 7.93-11.40), while cemiplimab demonstrated a high point estimate (ROR 10.56)...The CTLA-4 inhibitor ipilimumab yielded substantial disproportionality (n = 54; ROR 12.77, 95% CI 9.76-16.70), and the LAG-3 inhibitor relatlimab showed a comparable signal (ROR 12.64) despite limited case numbers.ConclusionsThis analysis confirms HLH as a significant class-wide toxicity of immune checkpoint blockade, with robust safety signals observed for pembrolizumab, atezolizumab, and ipilimumab. These findings underscore the critical need for heightened clinical vigilance and rapid diagnostic evaluation for HLH in patients presenting with hyperinflammatory symptoms during immunotherapy.
    Journal • Adverse events • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc) • relatlimab (BMS-986016)
    12d
    The game changer in the cervical cancer therapeutic landscape: immunotherapy. (PubMed, Immunotherapy)
    The incorporation of Immune Checkpoint Inhibitors such as pembrolizumab and cemiplimab in the CC treatment has led to significant improvements in survival. Together, these strategies represent a dynamic immuno-oncology landscape with the potential to redefine treatment paradigms in cervical cancer. Ongoing clinical trials and translational studies will be key to identifying optimal combinations, timing, and patient populations most likely to derive durable benefit from these new interventions.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Libtayo (cemiplimab-rwlc)
    16d
    Capecitabine In Combination With Cemiplimab In Patient With Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=13, Completed, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative
    |
    capecitabine • Libtayo (cemiplimab-rwlc)
    16d
    PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Yervoy (ipilimumab) • Libtayo (cemiplimab-rwlc) • fianlimab (REGN3767)