Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 350 mg/7 mL [50 mg/mL]) |
| Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation
- Indicated for the treatment of patients with locally advanced or metastatic basal cell carcinoma (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
- Indicated, in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation
- Indicated, in combination with platinum-based chemotherapy for the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations and is metastatic
- Indicated as a single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is locally advanced where patients are not candidates for surgical resection or definitive chemoradiation
- Indicated as a single agent for the first-line treatment of adult patients with NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations, and is metastatic.
Latest News
Summary
- This summary is based on the review of 17 systematic review(s)/meta-analysis(es). [1-17]
- Cemiplimab demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) in multiple studies, often ranking highly compared to other immune checkpoint inhibitors (ICIs) such as pembrolizumab, atezolizumab, and nivolumab. It showed superior OS in subgroups like male patients and those with squamous non-small cell lung cancer (NSCLC).
- Camrelizumab plus chemotherapy had the highest probability of efficacy for OS and PFS in patients with PD-L1 expression ≥50%, while sintilimab plus chemotherapy provided the best OS for PD-L1 non-selective patients.
- Objective response rate (ORR) was elevated for cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC) and for atezolizumab plus bevacizumab plus chemotherapy in comparison to chemotherapy alone, reflecting superior effectiveness in achieving treatment response.
- Cemiplimab was associated with the lowest incidence of any-grade adverse events (AEs) in advanced NSCLC patients without PD-L1 selection, while adding chemotherapy to ICIs increased the risk of severe AEs.
- Dual immunotarget inhibitors (programmed death 1 (PD-1) + cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4)) were linked to higher cardiotoxicity, and PD-1 inhibitors, including nivolumab, pembrolizumab, and cemiplimab, had a higher incidence of colitis compared to PD-L1 inhibitors such as atezolizumab.
- Male patients treated with cemiplimab had better overall survival but experienced a higher incidence of severe AEs, such as colitis, compared to females.
- Subgroup analyses identified specific population differences in response to treatment. Camrelizumab plus chemotherapy was most effective in patients with PD-L1 expression ≥50%, while cemiplimab demonstrated better overall survival in male patients compared to females. Patients with central nervous system (CNS) metastases benefited most from combination therapies like nivolumab plus ipilimumab plus chemotherapy.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Libtayo (cemiplimab-rwlc) Prescribing Information. | 2024 | Regeneron Pharmaceuticals, Inc., Tarrytown, NY |