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Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation (FDA.gov).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Cemiplimab||Libtayo||REGN2810|SAR439684||Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 68||Libtayo (cemiplimab) is a human antibody that targets PD-1 (PDCD1) and prevents interaction with PD-L1 (CD274) and PD-L2 (PDCD1LG2), potentially resulting in increased anti-tumor immune response and decreased tumor growth (PMID: 28265006). Libtayo (cemiplimab) is FDA approved for use in patients with cutaneous squamous cell carcinoma, who are not not eligible for curative surgery or radiation, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, and as first-line treatment in patients with advanced n0n-small cell lung cancer with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||basal cell carcinoma||not applicable||Cemiplimab||FDA approved||Actionable||In a Phase II trial (Study 1620) that supported FDA approval, Libtayo (cemiplimab) treatment resulted in an objective response rate of 31% (26/84, 5 complete responses, 21 partial responses) in patients with advanced or metastatic basal cell carcinoma who had received or were ineligible for a hedgehog pathway inhibitor, with median duration of response not reached, and an estimated progression-free survival of 10 months (Annals of Oncology (2020) 31 (suppl_4): S1142-S1215; NCT03132636).||detail... detail...|
|Unknown unknown||squamous cell carcinoma||not applicable||Cemiplimab||FDA approved||Actionable||In a Phase I and a Phase II trial that supported FDA approval, Libtayo (cemiplimab) treatment resulted in an objective response rate of 46.7% (35/75), a complete response rate of 5.3% (4/75), and a partial response rate of 41.3% (31/75) in patients with metastatic cutaneous squamous cell carcinoma (PMID: 29863979; NCT02383212, NCT02760498).||detail... 29863979|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03969004||Phase III||Cemiplimab||Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma||Active, not recruiting||USA | CAN||14|
|NCT02383212||Phase I||Carboplatin + Cemiplimab + Docetaxel Carboplatin + Cemiplimab + Pemetrexed Disodium Cemiplimab + Cyclophosphamide + Sargramostim Cemiplimab + Cyclophosphamide Cemiplimab Carboplatin + Cemiplimab + Paclitaxel Cemiplimab + Docetaxel||Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies||Completed||USA||2|
|NCT04428671||Phase I||Cemiplimab||Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer||Recruiting||USA||0|
|NCT02651662||Phase I||Cemiplimab Cemiplimab + Odronextamab||Study of REGN2810 and REGN1979 in Patients With Lymphoma||Active, not recruiting||USA||2|
|NCT03916627||Phase II||Cemiplimab||Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC||Recruiting||USA||0|
|NCT03690869||Phase Ib/II||Cemiplimab||REGN2810 in Pediatric Patients With Relapsed, Refractory Solid, or Central Nervous System (CNS) Tumors and Safety and Efficacy of REGN2810 in Combination With Radiotherapy in Pediatric Patients With Newly Diagnosed or Recurrent Glioma||Recruiting||USA||0|
|NCT03889912||Phase I||Cemiplimab||Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma||Active, not recruiting||USA||0|
|NCT03565783||Phase II||Cemiplimab||Study of REGN2810 Prior to Surgery in Patients With Advanced-Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck||Recruiting||USA||0|
|NCT03257267||Phase III||Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan||Study of REGN2810 in Adults With Cervical Cancer||Active, not recruiting||USA | CAN||12|
|NCT03477864||Phase I||Ipilimumab Cemiplimab + Ipilimumab Cemiplimab||Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer||Withdrawn||0|
|NCT02760498||Phase II||Cemiplimab||Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma||Recruiting||USA||8|
|NCT03580694||Phase I||Cemiplimab + REGN4659 Cemiplimab||Study of REGN4659 in Combination With Cemiplimab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)||Terminated||USA||0|
|NCT03669718||Phase II||Cemiplimab + ISA101b Cemiplimab||A Randomized Phase 2 Study of Cemiplimab +/- ISA101b in HPV16-Positive OPC||Recruiting||USA||9|
|NCT04315701||Phase II||Cemiplimab||A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer||Recruiting||USA||0|
|NCT03132636||Phase II||Cemiplimab||PD-1 in Patients With Advanced Basal Cell Carcinoma Who Experienced Progression of Disease on Hedgehog Pathway Inhibitor Therapy, or Were Intolerant of Prior Hedgehog Pathway Inhibitor Therapy||Active, not recruiting||USA | CAN||8|
|NCT04387084||Phase I||Durvalumab Pembrolizumab Avelumab Cemiplimab Atezolizumab Nivolumab||Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy||Not yet recruiting||USA||0|
|NCT04339062||Phase I||Cemiplimab Cemiplimab + Everolimus + Prednisone Cemiplimab + Prednisone + Sirolimus||Cemiplimab in AlloSCT/SOT Recipients With CSCC (CONTRAC)||Recruiting||USA||0|
|NCT03430063||Phase II||Cemiplimab + Ipilimumab Cemiplimab||A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer||Active, not recruiting||USA||8|
|NCT03409614||Phase III||Cemiplimab + Ipilimumab Cemiplimab||Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer||Active, not recruiting||USA||18|
|NCT04154943||Phase II||Cemiplimab||Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma||Recruiting||USA||2|