Cemiplimab
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Also known as Cemiplimab rwlcCemiplimab-rwlcLibtayoREGN-2810Regn2810
Summary
Cemiplimab (CHEMBL4297723) is an approved antibody (ATC L01FF06) targeting PDCD1; indicated across 37 conditions including squamous cell carcinoma and basal cell carcinoma.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Antibody
- ATC class: L01FF06
- Targets: 1 (PDCD1)
- Indications: 37 conditions
- Clinical trials: 197
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297723 |
| Name | Cemiplimab |
| Type | Antibody |
| Max phase | 4 |
| ATC | L01FF06 |
Also known as: Cemiplimab, Cemiplimab rwlc, Cemiplimab-rwlc, Libtayo, REGN-2810, Regn2810, REGN2810, CEMIPLIMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| PDCD1 | programmed cell death 1 (CD279) | Binding | 8.21 | 0% | Q15116 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): PDCD1.
Top Reactome pathways
3 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Co-inhibition by PD-1 | 1 | PDCD1 |
| Potential therapeutics for SARS | 1 | PDCD1 |
| PD-L1(CD274) glycosylation and translocation to plasma membrane | 1 | PDCD1 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| B cell apoptotic process | 1 |
| adaptive immune response | 1 |
| negative regulation of tolerance induction | 1 |
| negative regulation of T cell mediated immune response to tumor cell | 1 |
| negative regulation of B cell apoptotic process | 1 |
| apoptotic process | 1 |
| humoral immune response | 1 |
| negative regulation of inflammatory response | 1 |
| regulation of immune response | 1 |
| negative regulation of immune response | 1 |
| negative regulation of T cell receptor signaling pathway | 1 |
| negative regulation of T cell activation | 1 |
| positive regulation of T cell apoptotic process | 1 |
| regulatory T cell apoptotic process | 1 |
| immune system process | 1 |
Indications & clinical
Indications
37 indications (6 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| squamous cell carcinoma | 4 | MONDO:0005096 | EFO:0000707 |
| basal cell carcinoma | 4 | MONDO:0020804 | EFO:0004193 |
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| head and neck squamous cell carcinoma | 4 | MONDO:0010150 | EFO:0000181 |
| lung neoplasm | 4 | MONDO:0021117 | MONDO:0008903 |
| melanoma | 3 | MONDO:0005105 | EFO:0000756 |
| non-small cell lung carcinoma | 3 | MONDO:0005233 | EFO:0003060 |
| glioblastoma | 2 | MONDO:0018177 | EFO:0000519 |
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| Hodgkins lymphoma | 2 | MONDO:0004952 | EFO:0000183 |
| plasma cell myeloma | 2 | MONDO:0009693 | EFO:0001378 |
| exocrine pancreatic carcinoma | 2 | MONDO:0005192 | EFO:0002618 |
| angiosarcoma | 2 | MONDO:0016982 | EFO:0003968 |
| breast neoplasm | 2 | MONDO:0021100 | MONDO:0007254 |
| oropharynx cancer | 2 | MONDO:0004608 | MONDO:0044926 |
| cutaneous neuroendocrine carcinoma | 2 | MONDO:0019210 | EFO:1001471 |
| skin neoplasm | 2 | MONDO:0002531 | MONDO:0002898 |
| dedifferentiated liposarcoma | 2 | MONDO:0020563 | EFO:0003085 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| renal cell carcinoma | 1 | MONDO:0005086 | EFO:0000681 |
| HIV infectious disease | 1 | MONDO:0005109 | EFO:0000764 |
| hepatitis B virus infection | 1 | MONDO:0005344 | EFO:0004197 |
| metastatic neoplasm | 1 | MONDO:0024883 | EFO:0009709 |
| diffuse intrinsic pontine glioma | 1 | MONDO:0006033 | EFO:1000026 |
| fallopian tube neoplasm | 1 | MONDO:0021092 | MONDO:0002158 |
| ovarian cancer | 1 | MONDO:0008170 | MONDO:0008170 |
| neoplasm of mature B-cells | 1 | MONDO:0004949 | EFO:0000096 |
| head and neck cancer | 1 | MONDO:0005627 | EFO:0006859 |
| mycosis fungoides | 1 | MONDO:0009691 | EFO:1001051 |
| gastric neoplasm | 1 | MONDO:0021085 | MONDO:0001056 |
7 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 197.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 97 |
| PHASE1 | 38 |
| PHASE1/PHASE2 | 36 |
| PHASE3 | 13 |
| Not specified | 10 |
| PHASE2/PHASE3 | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT03969004 | PHASE3 | ACTIVE_NOT_RECRUITING | Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma |
| NCT05317858 | PHASE3 | RECRUITING | Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets |
| NCT05352672 | PHASE3 | ACTIVE_NOT_RECRUITING | Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma |
| NCT05608291 | PHASE3 | ACTIVE_NOT_RECRUITING | A Trial to See if the Combination of Fianlimab With Cemiplimab Works Better Than Pembrolizumab for Preventing or Delaying Melanoma From Coming Back After it Has Been Removed With Surgery |
| NCT05785767 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | 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) |
| NCT05800015 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | 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 |
| NCT06246916 | PHASE3 | RECRUITING | A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head) |
| NCT06585410 | PHASE3 | RECRUITING | Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma |
| NCT06616584 | PHASE2/PHASE3 | RECRUITING | Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy (An Expanded Lung-MAP Treatment Trial) |
| NCT06908304 | PHASE3 | RECRUITING | A Phase III Study With THIO + Cemiplimab vs Chemotherapy as 3rd Line Treatment in Advanced/Metastatic NSCLC |
| NCT06931717 | PHASE3 | RECRUITING | 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 |
| NCT03088540 | PHASE3 | COMPLETED | Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) |
| NCT03257267 | PHASE3 | COMPLETED | Study of Cemiplimab in Adults With Cervical Cancer |
| NCT03409614 | PHASE3 | COMPLETED | Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer |
| NCT03515629 | PHASE3 | TERMINATED | REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer |
| NCT06568172 | PHASE3 | SUSPENDED | Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer |
| NCT01042379 | PHASE2 | RECRUITING | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer |
| NCT03294083 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma |
| NCT03491683 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | INO-5401 and INO-9012 Delivered by Electroporation (EP) in Combination With Cemiplimab (REGN2810) in Newly-Diagnosed Glioblastoma (GBM) |
| NCT03564340 | PHASE1/PHASE2 | RECRUITING | Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers |
| NCT03565783 | PHASE2 | ACTIVE_NOT_RECRUITING | Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before Surgery |
| NCT03916627 | PHASE2 | ACTIVE_NOT_RECRUITING | Neoadjuvant Cemiplimab for the Treatment of Resectable NSCLC, HCC, and HNSCC in Adult Patients |
| NCT03951831 | PHASE2 | ACTIVE_NOT_RECRUITING | REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer |
| NCT03972657 | PHASE1/PHASE2 | RECRUITING | A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors |
| NCT04050436 | PHASE2 | ACTIVE_NOT_RECRUITING | Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer |
| NCT04243616 | PHASE2 | ACTIVE_NOT_RECRUITING | Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer |
| NCT04291105 | PHASE2 | RECRUITING | Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients |
| NCT04305795 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors |
| NCT04315701 | PHASE2 | ACTIVE_NOT_RECRUITING | A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer |
| NCT04543071 | PHASE2 | RECRUITING | Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma |
| NCT04590326 | PHASE1/PHASE2 | RECRUITING | A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab |
| NCT04626635 | PHASE1/PHASE2 | RECRUITING | A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers |
| NCT04632433 | PHASE2 | ACTIVE_NOT_RECRUITING | Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma |
| NCT04706715 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | LAG3 PET Imaging in Advanced Solid Tumors |
| NCT04862650 | PHASE2 | ACTIVE_NOT_RECRUITING | Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck |
| NCT04988074 | PHASE2 | RECRUITING | Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca |
| NCT04989946 | PHASE1/PHASE2 | RECRUITING | Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer |
| NCT05208944 | PHASE2 | ACTIVE_NOT_RECRUITING | THIO Sequenced With Cemiplimab in Advanced NSCLC |
| NCT05401786 | PHASE2 | ACTIVE_NOT_RECRUITING | Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC |
| NCT05501665 | PHASE1/PHASE2 | RECRUITING | Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.
4 molecules share ≥1 primary target. Top 4 by shared-target count:
| Molecule | Source | Status | Shared targets |
|---|---|---|---|
| PYRVINIUM | ChEMBL | Phase 4 (approved) | PDCD1 |
| RIFABUTIN | ChEMBL | Phase 4 (approved) | PDCD1 |
| Gefitinib | PubChem | Approved | PDCD1 |
| Pomalidomide | PubChem | Approved | PDCD1 |