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, in patients with locally advanced or metastatic basal cell carcinoma who have received or are not eligible for a hedgehog pathway inhibitor, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cemiplimab | Libtayo | REGN2810|SAR439684 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | 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, as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) with high PD-L1 expression (TPS>=50%) and no EGFR, ALK, or ROS1 aberrations, and in combination with platinum-based chemotherapy as first-line treatment for patients with NSCLC without EGFR, ALK, or ROS1 alterations (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| CD274 over exp | lung adenocarcinoma | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines as preferred first-line therapy for patients with advanced or metastatic lung adenocarcinoma with CD274 (PD-L1) expression of at least 50% and negative for actionable molecular biomarkers; and as continued maintenance therapy (NCCN.org). | detail... |
| CD274 positive | lung non-small cell carcinoma | predicted - sensitive | Cemiplimab | Phase III | Actionable | In a Phase III trial (EMPOWER-Lung 3), first-line Libtayo (cemiplimab) and platinum-doublet chemotherapy combination treatment (n=217) significantly improved median overall survival (23.5 vs 12.1 mo, HR=0.51, p<0.0001) and median progression-free survival (8.3 vs 5.5 mo, HR=0.48, p<0.0001) compared to chemotherapy and placebo (n=110) in patients with advanced non-small cell lung cancer with CD274 (PD-L1) expression >/= 1% and without EGFR, ALK, or ROS1 aberrations (PMID: 38820979; NCT03409614). | 38820979 |
| CD274 over exp | lung non-small cell carcinoma | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines as preferred first-line therapy for patients with advanced or metastatic non-small cell lung cancer, not otherwise specified, with CD274 (PD-L1) expression of at least 50% and negative for actionable molecular biomarkers; and as continued maintenance therapy (NCCN.org). | detail... |
| CD274 over exp | lung non-small cell carcinoma | sensitive | Cemiplimab | Phase III | Actionable | In a phase III trial (EMPOWER-Lung 1), Libtayo (cemiplimab) therapy improved overall survival (18.7 vs 11.7 mo, HR 0.17, p=0.0091), progression-free survival (10.4 vs 5.3 mo, HR 0.45, p=0.0231), and objective response rate (41.2% vs 8.8%) compared to chemotherapy in patients with advanced non-small cell lung cancer with CD274 (PD-L1) expression equals to or over 50% and with brain metastases at baseline (J Clin Oncol 39, no. 15_suppl (May 20, 2021) 9085-9085; NCT03088540). | detail... |
| CD274 over exp | penis squamous cell carcinoma | predicted - sensitive | Cemiplimab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with metastatic squamous cell carcinoma of the penis harboring CDKN2A R80* with high CD274 (PD-L1) expression (IHC>95%) previously treated with cisplatin-based chemotherapy and radiotherapy achieved a complete response to treatment with Libtayo (cemiplimab), and maintained the complete response six months after treatment cessation (PMID: 34267641). | 34267641 |
| CD274 over exp | lung squamous cell carcinoma | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines as preferred first-line therapy for patients with advanced or metastatic lung squamous cell carcinoma with CD274 (PD-L1) expression of at least 50% and negative for actionable molecular biomarkers; and as continued maintenance therapy (NCCN.org). | detail... |
| CD274 over exp | lung large cell carcinoma | sensitive | Cemiplimab | Guideline | Actionable | Libtayo (cemiplimab) is included in guidelines as preferred first-line therapy for patients with advanced or metastatic lung large cell carcinoma with CD274 (PD-L1) expression of at least 50% and negative for actionable molecular biomarkers; and as continued maintenance therapy (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03889912 | Phase I | Cemiplimab | Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent Cutaneous Squamous Cell Carcinoma | Recruiting | USA | 0 |
| NCT05878288 | Phase II | Cemiplimab | Deep sequencIng in Cutaneous Squamous CEll caRciNomas (DISCERN) | Active, not recruiting | AUS | 0 |
| NCT05538988 | Phase Ib/II | Cemiplimab | BIOmarker-guided Study to Evaluate the Efficacy and Safety of cemipLimab for advancEd Cutaneous T-cell Lymphoma (BIOSELECT) | Not yet recruiting | CAN | 0 |
| NCT04975152 | Phase I | Cemiplimab | Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Carcinoma and Locoregionally Advanced Cutaneous Squamous Cell Carcinoma | Recruiting | USA | 0 |
| NCT04632433 | Phase II | Cemiplimab | Neoadjuvant Plus Adjuvant Treatment With Cemiplimab in Cutaneaous Squamous Cell Carcinoma | Active, not recruiting | ITA | 0 |
| NCT04873375 | Phase II | Cemiplimab | Cemiplimab for Secondary Angiosarcomas | Completed | NLD | 0 |
| 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 | |
| NCT06743581 | Phase Ib/II | Cemiplimab Dupilumab | Phase I/II Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer (Dupi-Cemi) | Not yet recruiting | CAN | 0 |
| NCT04428671 | Phase I | Cemiplimab | Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer | Recruiting | USA | 0 |
| NCT06449313 | Phase II | Cemiplimab | Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advanced Non-small Cell Lung Cancer With N3 Lymph Node Involvement (NEO-SURG) | Not yet recruiting | USA | 0 |
| NCT04339062 | Phase I | Cemiplimab Cemiplimab + Everolimus + Prednisone Cemiplimab + Prednisone + Sirolimus | Cemiplimab in AlloSCT/SOT Recipients With CSCC (CONTRAC) | Active, not recruiting | USA | 0 |
| 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 | Terminated | USA | 0 |
| NCT05840770 | Phase II | Cemiplimab | Cemiplimab for the Treatment of Untreated Brain Metastases From PD-L1 >= 50% Non-Small Cell Lung Cancer | Recruiting | USA | 0 |
| NCT05967884 | Phase II | Cemiplimab Cemiplimab + Dupilumab | PD-1 +/- IL-4 Inhibition in ER+ Breast Cancer | Not yet recruiting | CAN | 0 |
| NCT06385262 | Phase II | Cemiplimab Alirocumab + Cemiplimab | TOP 2301: Neoadjuvant Chemo for NSCLC | Recruiting | USA | 0 |
| NCT06568172 | Phase III | Cemiplimab | Testing the Addition of an Immunotherapy Drug, Cemiplimab (REGN2810), Plus Surgery to the Usual Surgery Alone for Treating Advanced Skin Cancer | Recruiting | USA | 0 |
| NCT04526899 | Phase II | Cemiplimab BNT111 BNT111 + Cemiplimab | Trial With BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Anti-PD1-refractory/Relapsed, Unresectable Stage III or IV Melanoma | Active, not recruiting | USA | POL | ITA | GBR | ESP | DEU | AUS | 0 |
| NCT06205836 | Phase II | Cemiplimab Cemiplimab + Fianlimab | Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer | Recruiting | USA | 0 |
| NCT04154943 | Phase II | Cemiplimab | Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma | Active, not recruiting | USA | DEU | AUS | 0 |
| NCT06219317 | Phase II | Cemiplimab | Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC (ICARS) | Not yet recruiting | NLD | ITA | FRA | ESP | BEL | 0 |
| NCT05352672 | Phase III | Cemiplimab Cemiplimab + Fianlimab Pembrolizumab | Clinical Study of Fianlimab in Combination With Cemiplimab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma | Recruiting | USA | TUR | ROU | POL | NLD | ITA | IRL | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 5 |
| NCT05401786 | Phase II | Cemiplimab Ipilimumab | Anti-PD-1 Re-challenge After Immune Priming by Ipilimumab and Immune Boosting by Radiotherapy in Advanced NSCLC (RAD-IO) | Recruiting | NLD | 0 |
| NCT03430063 | Phase II | Cemiplimab + Ipilimumab Cemiplimab | A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer | Terminated | USA | POL | GBR | FRA | ESP | DEU | BEL | 2 |
| NCT04988074 | Phase II | Cemiplimab Carboplatin + Cemiplimab + Paclitaxel | Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca (MINIMA) | Recruiting | USA | 0 |
| NCT05574101 | Phase II | Cemiplimab | A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer | Active, not recruiting | USA | 0 |
| NCT06162572 | Phase Ib/II | Cemiplimab + S095029 Cemiplimab + Sym024 Cemiplimab + Sym023 Cemiplimab | Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) | Recruiting | USA | ROU | ITA | HUN | GBR | FRA | ESP | BRA | BEL | AUT | AUS | ARG | 3 |
| 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 | POL | NZL | ITA | IRL | GRC | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | 2 |
| NCT02760498 | Phase II | Cemiplimab | Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma | Completed | USA | ITA | GRC | FRA | ESP | DEU | BRA | AUS | 0 |
| NCT05961709 | Phase II | Cemiplimab | The Phoenix Trial: Phase II Trial of Cemiplimab for the Non-operative Management of Localized dMMR Colon Cancer | Recruiting | USA | 0 |
| NCT06465329 | Phase II | Cemiplimab + REGN7075 REGN7075 Cemiplimab | A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) | 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 | Active, not recruiting | USA | 0 |
| NCT05344209 | Phase II | Atezolizumab Pembrolizumab Cemiplimab Cemiplimab + Sargramostim + UV1 Telomerase peptide vaccine Pembrolizumab + Sargramostim + UV1 Telomerase peptide vaccine Atezolizumab + Sargramostim + UV1 Telomerase peptide vaccine | Efficacy and Safety of Anti-PD-1/PD-L1 Treatment +/- UV1 Vaccination in Patients With Non-small Cell Lung Cancer (LUNGVAC) | Recruiting | NOR | 0 |
| 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 | ESP | AUS | 0 |
| 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 | Active, not recruiting | USA | 0 |
| NCT06623656 | Phase II | Cemiplimab | Preoperative Radioimmunotherapy Versus Chemoimmunotherapy in NSCLC | Not yet recruiting | USA | 0 |
| 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 |
| NCT05929664 | Phase II | Cemiplimab | Cemiplimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery | Recruiting | USA | 0 |
| NCT05557591 | Phase II | Cemiplimab BNT116 + Cemiplimab | A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1) | Recruiting | USA | TUR | ESP | DEU | 3 |
| NCT01042379 | Phase II | Trilaciclib Trastuzumab Duocarmazine Cyclophosphamide + Doxorubicin Cemiplimab Amcenestrant Abemaciclib + Amcenestrant Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel + Trastuzumab Amcenestrant + Letrozole Carboplatin + Dostarlimab-gxly + HM30181A + Paclitaxel Pertuzumab + Trastuzumab + Trilaciclib Paclitaxel + Trastuzumab Pertuzumab + Trastuzumab Cemiplimab + Fianlimab | I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (I-SPY) | Recruiting | USA | 0 |
| NCT02651662 | Phase I | Cemiplimab Cemiplimab + Odronextamab | Study of REGN2810 and REGN1979 in Patients With Lymphoma | Recruiting | USA | POL | ISR | ESP | DEU | AUT | 0 |
| NCT06190951 | Phase II | Pembrolizumab Cemiplimab Cemiplimab + Fianlimab | A Trial to Learn if Fianlimab and Cemiplimab Are Safe and Work Better Than Anti-PD1 Alone in Adult Participants With Resectable Stage 3 or 4 Melanoma | Recruiting | USA | 0 |
| NCT04315701 | Phase II | Cemiplimab | A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer | Recruiting | USA | 0 |
| 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 | TUR | SVK | ROU | POL | LTU | ITA | IRL | GRC | FRA | AUT | 7 |
| NCT05785767 | Phase II | Cemiplimab Cemiplimab + Fianlimab | 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) | Recruiting | USA | TUR | ISR | CAN | AUS | 5 |
| 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 | Completed | USA | ITA | GRC | FRA | ESP | DEU | CHE | CAN | BEL | AUT | 0 |
| NCT03257267 | Phase III | Irinotecan Gemcitabine Vinorelbine Pemetrexed Disodium Cemiplimab Topotecan | Study of REGN2810 in Adults With Cervical Cancer | Completed | USA | POL | ITA | GRC | GBR | ESP | CAN | BRA | BEL | AUS | 4 |
| NCT03669718 | Phase II | Cemiplimab + ISA101b Cemiplimab | A Randomized Phase 2 Study of Cemiplimab +/- ISA101b in HPV16-Positive OPC | Active, not recruiting | USA | POL | NLD | ITA | HUN | GBR | FRA | ESP | DEU | CZE | BRA | BEL | 1 |
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