Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 350 mg/7 mL) |
| Drug Class | Programmed death receptor-1 (PD-1) blocking antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
- 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.
- 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, or metastatic.
- As 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, or metastatic.
Summary
- Cemiplimab-rwlc (Libtayo) is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or radiation, and in combination with platinum-based chemotherapy for first-line treatment of adult patients with non-small cell lung cancer.
- The drug has also been approved as a single agent for the first-line treatment of adult patients whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) ≥ 50%] without EGFR, ALK or ROS1 aberrations.
- In terms of effectiveness, cemiplimab-rwlc (Libtayo) ranked first in overall survival among treatments for Advanced NSCLC without PD-L1 selection and showed lower incidents of any-grade adverse events compared to other immunotherapies.
- For Squamous NSCLC Subgroup, cemiplimab-rwlc (Libtayo), alongside sugemalimab plus chemotherapy was highly effective ranking first in overall survival indicating its potent efficacy within this subgroup.
- When treating advanced Cutaneous Squamous Cell Carcinoma where surgery isn't an option, Libtayo demonstrated rapid antitumor efficacy while maintaining acceptable safety levels making it a promising therapeutic option.
- Compared to Platinum-based Chemotherapy and EGFR inhibitors used in Advanced CSCC cases; indirect comparison suggested superior OS and progression-free survival benefits from using Libtayo thus establishing it as more efficacious alternative therapy choice.
- Safety profile assessment revealed that cemiplimab-rwlc had lowest rates of any-grade adverse events when used on Advanced NSCLC without PD-L1 Selection suggesting favorable safety profile over other ICIs regimens available currently.
- The information provided is based on systematic reviews/meta-analyses conducted across 12 different studys which were thoroughly reviewed to provide a comprehensive understanding of the drug's safety and effectiveness.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Libtayo (cemiplimab-rwlc) Prescribing Information. | 2021 | Regeneron Pharmaceuticals, Tarrytown, NY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Japanese Dermatological Association guidelines: outlines of guidelines for cutaneous squamous cell carcinoma 2020. | 2021 | The Journal of Dermatology |
| European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: part 2. Treatment. | 2020 | European Journal of Cancer |