Welcome to our latest edition of the Guidelines+ Monographs Series, where we delve into the medication cemiplimab-rwlc, marketed under the brand name Libtayo® by Regeneron. Libtayo is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC), locally advanced or metastatic basal cell carcinoma (laBCC or mBCC), and non-small cell lung cancer (NSCLC). It was initially approved in 2018.
In the following sections, we will provide a comprehensive overview of cemiplimab-rwlc and analyze its positioning across various guidelines for its approved indications.
Note* - This Guidelines+ Monographs for cemiplimab-rwlc (Libtayo) is current as of February 2025. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
- Brand name: Libtayo
- Generic name: cemiplimab-rwlc
- Manufacturer(s): Regeneron
- Initial FDA Approval: September 2018
Indications and FDA Approval Details
Indicated Condition | Indicated | Age | Date Approved |
|---|---|---|---|
Cutaneous Squamous Cell Carcinoma (CSCC) | 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. | Adults | September 28, 2018 |
| Basal Cell Carcinoma (BCC) | For the treatment of patients with locally advanced or metastatic BCC (laBCC or mBCC) who have been previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. | Adults | February 9, 2021 |
| Non-Small Cell Lung Cancer (NSCLC) | 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 - 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 - metastatic. | Adults | November 8, 2022 |
Dosage and Administration
- Administer LIBTAYO as an intravenous infusion over 30 minutes after dilution.
- CSCC and BCC: 350 mg every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months.
- NSCLC: 350 mg every 3 weeks until disease progression or unacceptable toxicity
Dosage Forms and Strengths
- Injection: 350 mg/7 mL (50 mg/mL) solution in a single-dose vial.
Contraindications
- None
Warnings and Precautions
- Immune-Mediated Adverse Reactions
- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immunemediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
- Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
- Withhold or permanently discontinue LIBTAYO based on the severity of reaction.
- Infusion-Related Reactions: Interrupt, slow the rate of infusion, or permanently discontinue based on severity of reaction.
- Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT): Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
- Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.
- Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immunemediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection.
Adverse Reactions
- LIBTAYO as a Single Agent:
- The most common adverse reactions (≥15%) are fatigue, musculoskeletal pain, rash, diarrhea, and anemia.
- LIBTAYO in Combination with Platinum-based Chemotherapy
- The most common adverse reactions (≥15%) are alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite.
Now that we’ve covered the basic monograph information for Libtayo, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Cemiplimab-rwlc in the Guidelines
| Indication | Guideline | Society | Recommendation | Strength |
|---|---|---|---|---|
| Nonsquamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | PD-L1 expression -TPS ≥50%Recommend that clinicians offer pembrolizumab or cemiplimab or atezolizumab as a single agent | Strong |
| Nonsquamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | PD-L1 expression -TPS ≥50% Clinicians may offer pembrolizumab + carboplatin + pemetrexed or cemiplimab + carboplatin + pemetrexed | Weak |
| Nonsquamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | PD-L1 expression TPS, 1%-49% Clinicians should offer pembrolizumab + carboplatin + pemetrexed or cemiplimab + carboplatin + pemetrexed | Strong |
| Nonsquamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | Unknown or negative PD-L1 expression, TPS <1% Clinicians may offer pembrolizumab + carboplatin + pemetrexed or cemiplimab + carboplatin + pemetrexed | Weak |
| Squamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | PD-L1 expression, TPS ≥50% Clinicians should offer single-agent pembrolizumab or cemiplimab or atezolizumab | Strong |
| Squamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | PD-L1 expression, TPS ≥50% Clinicians may offer pembrolizumab + carboplatin + paclitaxel (or nab-paclitaxel) or cemiplimab + carboplatin + paclitaxel | Weak |
| Squamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | PD-L1 expression TPS, 1%-49% Clinicians should offer pembrolizumab + carboplatin + paclitaxel (or nab-paclitaxel) or cemiplimab + carboplatin + paclitaxel | Strong |
| Squamous cell carcinoma | Stage IV Non-Small Cell Lung Cancer without Driver Alterations | American Society of Clinical Oncology (ASCO) | Unknown or negative PD-L1 expression, TPS <1% Clinicians should offer pembrolizumab + carboplatin + paclitaxel (or nab-paclitaxel) or cemiplimab + carboplatin + paclitaxel | Weak |
| NSCLC | Immunotherapy for the Treatment of Lung Cancer and Mesothelioma | Society for Immunotherapy of Cancer (SITC) | For patients with metastatic NSCLC with no actionable mutations and TPS ≥50%, the panel recommends first-line pembrolizumab, atezolizumab, orcemiplimab monotherapy, with consideration forchemo-immunotherapy for patients with high tumordisease burden or worrisome symptoms | Level 2 |
| NSCLC | Immunotherapy for the Treatment of Nonmelanoma Skin Cancer | Society for Immunotherapy of Cancer (SITC) | Cemiplimab or pembrolizumab is appropriate first-line therapy for patients with metastatic or locally advanced CSCC who are not candidates for curative surgery or radiation. | Level 2 |
This concludes our Guidelines+ Monographs for cemiplimab-rwlc (Libtayo). This list is current as of February 2025, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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