Therapy Detail

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Therapy Name Cemiplimab
Synonyms
Therapy Description

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).

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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).

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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

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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


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