Also known as: Libtayo
Cemiplimab is a PD-1 checkpoint inhibitor monoclonal antibody marketed as Libtayo for multiple oncology indications. It is approved for cutaneous squamous cell carcinoma and additional cancers including basal cell carcinoma, NSCLC, and cervical cancer. It is administered intravenously and is prescription-only.
The C-POST trial shows adjuvant cemiplimab improves disease-free survival in high-risk cutaneous squamous cell carcinoma, with a hazard ratio of 0.32. Meanwhile, an international Phase III study is testing cemiplimab before surgery in advanced cases. Cemiplimab is FDA-approved for advanced skin cancer but not yet for pre-surgical use.
BioNTech presented phase 2 data for HER2-directed ADC Trastuzumab Pamirtecan showing 47.9% response rate in endometrial cancer, with FDA submission planned for 2026. BioLineRx dosed first patient in phase 1/2a GLIX1 trial for glioblastoma and reported new preclinical data. Both companies presented at ASCO 2026.
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
Recent studies demonstrate PD-1 antibody combinations improve survival in natural killer/T-cell lymphoma and show activity in previously treated advanced non-small cell lung cancer, with manageable safety profiles across treatment settings.
The FDA approved KEYTRUDA and its subcutaneous QLEX formulation for platinum-resistant ovarian cancer, marking the first PD-1 inhibitor cleared for this patient population based on Phase 3 results.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07567469 |
A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07527325 |
Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07511036 |
PROSECCO: A Phase 2, Single Arm, Neoadjuvant Study Evaluating Combination Cemiplimab, Fianlimab, And Ipilimumab In Patients With Surgically Resectable Melanoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07470489 |
Zanzalintinib Plus Cemiplimab for the Treatment of BRAF Wild-Type Anaplastic Thyroid Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07450183 |
Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 |
NOT_YET_RECRUITING | PHASE2 |
| NCT07433673 |
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC) |
RECRUITING | PHASE2 |
| NCT07422363 |
Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma |
NOT_YET_RECRUITING | PHASE1 |
| NCT07414992 |
A Study of Radiation Therapy and Cemiplimab With or Without Fianlimab In People With Bladder Cancer |
NOT_YET_RECRUITING | PHASE2 |
| NCT07404332 |
5-Azacitidine Plus PD-1/PD-L1 Inhibitor With PD-1/PD-L1 Refractory Tumors |
RECRUITING | PHASE1 |
| NCT07360743 |
Immunotherapy Without Chemotherapy for Advanced Lung Cancer Patients With High PD-L1 Levels |
NOT_YET_RECRUITING | PHASE2 |
