Cemiplimab-rwlc

(Libtayo®)

Libtayo®

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Drug updated on 5/17/2024

Dosage FormInjection (intravenous; 350 mg/7 mL)
Drug ClassProgrammed 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.

Summary
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  • Cemiplimab-rwlc (Libtayo) is an immune checkpoint inhibitor that targets the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) pathway, demonstrating significant effectiveness in treating various cancers including non-small cell lung cancer (NSCLC), cutaneous squamous cell carcinoma (CSCC), and potentially cervical cancer.
  • Nine systematic reviews/meta-analyses focused on Libtayo's safety and effectiveness compared to other therapies across various indications, with special attention given to population types and subgroup considerations.
  • In comparison with other therapies for NSCLC treatment, Libtayo demonstrated superior overall survival rates and a balanced safety profile in advanced NSCLC patients without PD-L1 selection. It outperformed some other immune checkpoint inhibitors as well as combinations of these inhibitors with platinum-based chemotherapy, presenting less toxicity.
  • For cutaneous squamous cell carcinoma treatment, Libtayo showed rapid antitumor efficacy with acceptable safety profiles. It surpassed EGFR inhibitors, pembrolizumab, and platinum-based chemotherapies in terms of overall survival rate and progression-free survival rate when used either as first-line or later treatments.
  • The response rates to cemiplimab-rwlc varied among different subgroups based on factors such as PD-L1 expression levels or primary tumor location, indicating potential influences which suggest a need for personalized treatment approaches based on these factors.
  • The incidence of adverse events associated with cemiplimab-rwlc was manageable compared to those related to other ICIs; it had a lower cardiotoxicity risk along with generally low rates of discontinuation due to adverse effects, making its safety profile favorable against many others.

Product Monograph / Prescribing Information

Document TitleYearSource
Libtayo (cemiplimab-rwlc) Prescribing Information.2021Regeneron Pharmaceuticals, Tarrytown, NY

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of cemiplimab in the treatment of advanced cutaneous squamous cell carcinoma: a multicentre real-world retrospective study from Spain and systematic review of the published data.2024Journal of The European Academy of Dermatology & Venereology
Comparison of the profiles of first-line PD-1/PD-L1 inhibitors for advanced NSCLC lacking driver gene mutations: a systematic review and Bayesian network meta-analysis. 2023Therapeutic advances in Chronic Diseases
Efficacy and safety of immune checkpoint inhibitors for advanced non-small cell lung cancer with or without PD-L1 selection: a systematic review and network meta-analysis. 2023Chinese Medical Journal
Cardiotoxicity of lung cancer-related immunotherapy versus chemotherapy: a systematic review and network meta-analysis of randomized controlled trials. 2023Frontiers in Oncology
Identifying optimal first-line immune checkpoint inhibitors based regiments for advanced non-small cell lung cancer without oncogenic driver mutations: a systematic review and network meta-analysis. 2023PLoS One
Immune checkpoint inhibitors in advanced cutaneous squamous cell carcinoma: a systemic review and meta-analysis. 2023Skin Research and Technology
Beyond platinum, ICIs in metastatic cervical cancer: a systematic review.2022Cancers
PD-(L)1 inhibitors as monotherapy for the first-line treatment of non-small-cell lung cancer patients with high pd-l1 expression: a network meta-analysis.2021Journal of Clinical Medicine
Cemiplimab in advanced cutaneous squamous cell carcinoma. 2021Dermatologic Therapy
Comparative efficacy of cemiplimab versus other systemic treatments for advanced cutaneous squamous cell carcinoma.2020Future Oncology

Clinical Practice Guidelines