Brand Name
Libtayo
Generic Name
Cemiplimab-Rwlc
View Brand Information FDA approval date: September 28, 2018
Form: Injection
What is Libtayo (Cemiplimab-Rwlc)?
LIBTAYO is a programmed death receptor-1 blocking antibody indicated: Cutaneous Squamous Cell Carcinoma for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Approved To Treat
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
An Observational Study to Assess the Effectiveness and Safety of Cemiplimab Based Regimen in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe (CEMI-LUNG)
Summary: This study is focused on patients with non-small cell lung cancer (NSCLC) and have been prescribed a cemiplimab (Libtayo®) based treatment regimen under standard care. The goal of this study is to learn more about the use, benefits, and safety of cemiplimab based treatment regimens in participants with NSCLC.
A Phase 2 Single-Arm Study of Neoadjuvant Chemo-Immunotherapy and Surgical Resection in Locally Advance Non-Small Cell Lung Cancer (NSCLC) With N3 Lymph Node Involvement
Summary: The goal of this clinical trial is to learn about neoadjuvant cemiplimab with histology-specific chemotherapy followed by resection and adjuvant cemiplimab in stage 3 non-small cell lung cancer (NSCLC) with contralateral mediastinal or ipsilateral supraclavicular lymph node (N3) involvement.. The main question it aims to answer is whether patients with stage 3 NSCLC with involvement of lymph nodes...
A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced With Cemiplimab (LIBTAYO®) in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
Summary: THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death. Cemiplimab is a programmed cell death protein 1 (PD-1) in...
Related Latest Advances
Brand Information
LIBTAYO (cemiplimab-rwlc)
1DOSAGE FORMS AND STRENGTHS
Injection: 350 mg/7 mL (50 mg/mL), clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles in a single-dose vial.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling.
- Severe and Fatal Immune-Mediated Adverse Reactions
- Infusion-Related Reactions
- Complications of Allogeneic HSCT
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described in Warnings and Precautions reflect exposure to LIBTAYO as a single agent in 1281 patients with advanced cancers in three open-label, single-arm, multicohort studies, and two open-label randomized multi-center studies. These studies included 384 patients with advanced CSCC (Studies 1540 and 1423), 138 patients with advanced BCC (Study 1620), 355 patients with NSCLC (Study 1624), and 404 patients with other advanced solid tumors. LIBTAYO was administered intravenously at doses of 3 mg/kg every 2 weeks (n=235), 350 mg every 3 weeks (n=1014), or other doses (n=32). Among the 1281 patients, 53% were exposed for 6 months or longer and 26% were exposed for one year or longer. In this pooled safety population, the most common adverse reactions (≥15%) were fatigue, musculoskeletal pain, rash, diarrhea, and anemia. The most common Grade 3-4 laboratory abnormalities (≥2%) were lymphopenia, anemia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, hypokalemia, hyperkalemia, and increased alanine aminotransferase.
The data below also reflect exposure to LIBTAYO as a single agent (either 350 mg every 3 weeks for 12 weeks followed by 700 mg every 6 weeks for 36 weeks or 350 mg every 3 weeks for 48 weeks) in the adjuvant setting in 205 patients with CSCC at high risk of recurrence after treatment with surgery and radiation (C-POST study), and LIBTAYO 350 mg every 3 weeks in combination with platinum-based chemotherapy in 312 patients with NSCLC enrolled in a randomized, active controlled trial (Study 16113).
Cutaneous Squamous Cell Carcinoma (CSCC)
Study 1540
The safety of LIBTAYO was evaluated in 358 patients with advanced CSCC (metastatic or locally advanced disease) in Study 1540
Serious adverse reactions occurred in 41% of patients. Serious adverse reactions that occurred in at least 2% of patients were pneumonia (3.6%), skin infection (3.6%), and pneumonitis (2.8%). Fatal adverse reactions occurred in 5% of patients who received LIBTAYO, including deaths due to infections (2.2%).
Permanent discontinuation due to an adverse reaction occurred in 12% of patients. Adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, rash, confusional state, general physical health deterioration, hemorrhage, liver function test abnormalities, and musculoskeletal pain.
Dosage interruptions of LIBTAYO due to an adverse reaction occurred in 36% of patients. Adverse reactions which required dosage interruption in ≥2% of patients included diarrhea, infusion-related reaction, upper respiratory tract infection, liver function test abnormalities, musculoskeletal pain, pneumonitis, and rash.
The most common (≥20%) adverse reactions were fatigue, rash, musculoskeletal pain, diarrhea, pruritus, and nausea. The most common Grade 3 or 4 adverse reactions (≥2%) were hypertension, skin infection, pneumonia, anemia, fatigue, musculoskeletal pain, and pneumonitis. The most common (≥4%) Grade 3 or 4 laboratory abnormalities worsening from baseline were lymphopenia, hyponatremia, anemia, and hypophosphatemia.
Table 3 summarizes the adverse reactions that occurred in ≥10% of patients and Table 4 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients receiving LIBTAYO.
Study 1423
In 26 patients with advanced CSCC treated with LIBTAYO in Study 1423
Adjuvant treatment of CSCC at high risk of recurrence
C-POST study
The safety of LIBTAYO was evaluated in patients with CSCC at high-risk of recurrence after surgery and radiation in the C-POST study
Patients were assigned to receive:
- LIBTAYO 350 mg (n=140) or placebo (n=140) intravenously every 3 weeks for 12 weeks, followed by 700 mg LIBTAYO or placebo intravenously every 6 weeks for an additional 36 weeks, or
- LIBTAYO 350 mg every 3 weeks (n=65) or placebo (n=64) for up to 48 weeks.
Treatment continued until disease recurrence, unacceptable toxicity, or up to 48 weeks.
The median duration of exposure was 48 weeks (range: 3 weeks to 52 weeks) in LIBTAYO-treated patients.
Serious adverse reactions occurred in 18% of patients who received LIBTAYO. Serious adverse reactions that occurred in ≥1% of patients in the LIBTAYO arm were pneumonia (1.5%), rash (1.5%), diarrhea (1.5%), adrenal insufficiency (1%), and arrhythmia (1%).
Permanent discontinuation due to an adverse reaction occurred in 10% of patients who received LIBTAYO. Adverse reactions resulting in permanent discontinuation in ≥1% of patients were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, and adrenal insufficiency.
Dosage interruptions due to an adverse reaction occurred in 22% of patients who received LIBTAYO. Adverse reactions leading to interruptions in ≥1% of patients included COVID-19, diarrhea, alanine aminotransferase increased, urinary tract infection, upper respiratory tract infection, aspartate aminotransferase increased, edema, dyspnea, pneumonitis, pneumonia, and rash.
Table 5 summarizes the adverse reactions that occurred in ≥10% of patients and Table 6 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients receiving LIBTAYO.
Basal Cell Carcinoma (BCC)
The safety of LIBTAYO was evaluated in 138 patients with advanced BCC (mBCC N=54, laBCC N=84) in an open-label, single-arm trial (Study 1620)
Serious adverse reactions occurred in 34% of patients. Serious adverse reactions that occurred in > 1.5% were diarrhea (3.6%), urinary tract infection (3.6%), pneumonia (2.9%), and hemorrhage (2.2%). Fatal adverse reactions occurred in 4.3% of patients who received LIBTAYO, including acute kidney injury (0.7%) and cachexia worsening due to colitis (0.7%).
Permanent discontinuation of LIBTAYO due to an adverse reaction occurred in 14% of patients. Adverse reactions resulting in permanent discontinuation of LIBTAYO in at least 2 patients were diarrhea, acute kidney injury, general physical health deterioration, and hepatitis.
Dosage interruptions of LIBTAYO due to an adverse reaction occurred in 40% of patients. Adverse reactions which required dosage interruptions in > 2% of patients included diarrhea, musculoskeletal pain, acute kidney injury, fatigue, fall, headache, infusion-related reaction, hemorrhage, pneumonitis, upper respiratory tract infection, and urinary tract infection.
The most common adverse reactions reported in at least 15% of patients were fatigue, musculoskeletal pain, diarrhea, rash, upper respiratory tract infection, pruritus, hemorrhage, and hypertension.
The most common Grade 3 or 4 adverse reactions (> 2%) were hypertension, diarrhea, fatigue, musculoskeletal pain, hypokalemia, hyponatremia, pneumonia, urinary tract infection, visual impairment, and weight decreased. The most common (> 2%) laboratory abnormalities worsening from baseline to Grade 3 or 4 were lymphopenia and hyponatremia.
Table 7 summarizes the adverse reactions that occurred in ≥10% of patients and Table 8 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥1% of patients receiving LIBTAYO.
Non-Small Cell Lung Cancer (NSCLC)
First-line treatment of NSCLC with LIBTAYO in Combination with Platinum-based Chemotherapy
The safety of LIBTAYO in combination with platinum-based chemotherapy was evaluated in 465 patients with locally advanced or metastatic NSCLC in Study 16113
Among patients who received LIBTAYO, 70% were exposed for 6 months or longer and 35% were exposed for greater than one year. The safety population characteristics were: median age of 63 years (25 to 82 years), 41% of patients 65 or older, 86% male, 86% White, 14% Asian, 86% had metastatic disease and 14% had locally advanced disease and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 (16%) and 1 (83%).
Serious adverse reactions occurred in 25% of patients. The most frequent serious adverse reactions that occurred in at least 2% of patients were pneumonia, anemia, and neutropenia. Fatal adverse reactions occurred in 6% of patients who received LIBTAYO in combination with chemotherapy, including death not otherwise specified (2.9%), sudden death (1.0%), acute hepatitis (0.3%), acute respiratory distress syndrome (0.3%), mesenteric artery thrombosis (0.3%), pneumonia (0.3%), pneumonitis (0.3%), and pulmonary hemorrhage (0.3%). LIBTAYO was permanently discontinued due to adverse reactions in 5% of patients. Adverse reactions resulting in permanent discontinuation in at least 2 patients were increased alanine aminotransferase and anemia.
Dosage interruptions of LIBTAYO due to an adverse reaction occurred in 33% of patients. Adverse reactions which required dosage interruptions in at least 2% of patients were anemia, pneumonia, neutropenia, thrombocytopenia, fatigue, COVID-19 infection, and pyrexia.
The most common (≥15%) adverse reactions were alopecia, musculoskeletal pain, nausea, fatigue, peripheral neuropathy, and decreased appetite. The most common Grade 3-4 laboratory abnormalities (≥2%) were anemia, neutropenia, lymphopenia, leukopenia, hyponatremia, thrombocytopenia, hyperglycemia, hypophosphatemia, increased alanine aminotransferase, hypocalcemia, hyperkalemia, hypermagnesemia, hypokalemia, and increased creatinine.
Table 9 summarizes the adverse reactions that occurred in ≥10% of patients and Table 10 summarizes Grade 3 or 4 laboratory abnormalities in patients receiving LIBTAYO and chemotherapy.
First-line treatment of NSCLC with LIBTAYO as a single agent
The safety of LIBTAYO was evaluated in 355 patients with locally advanced or metastatic NSCLC in Study 1624
The safety population characteristics were: median age of 63 years (31 to 79 years), 44% of patients 65 or older, 88% male, 86%White, 82% had metastatic disease and 18% had locally advanced disease, and ECOG performance score (PS) of 0 (27%) and 1 (73%).
LIBTAYO was permanently discontinued due to adverse reactions in 6% of patients; adverse reactions resulting in permanent discontinuation in at least 2 patients were pneumonitis, pneumonia, ischemic stroke, and increased aspartate aminotransferase. Serious adverse reactions occurred in 28% of patients. The most frequent serious adverse reactions in at least 2% of patients were pneumonia and pneumonitis.
Table 11 summarizes the adverse reactions that occurred in ≥10% of patients and Table 12 summarizes Grade 3 or 4 laboratory abnormalities in patients receiving LIBTAYO.
4DESCRIPTION
Cemiplimab-rwlc is a human programmed death receptor-1 (PD-1) blocking antibody. Cemiplimab-rwlc is a recombinant human IgG4 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2. Cemiplimab-rwlc is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. Cemiplimab-rwlc has an approximate molecular weight of 146 kDa.
LIBTAYO (cemiplimab-rwlc) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH of 6. The solution may contain trace amounts of translucent to white particles.
Each vial contains 350 mg of cemiplimab-rwlc. Each mL contains cemiplimab-rwlc 50 mg, L-histidine (0.74 mg), L-histidine monohydrochloride monohydrate (1.1 mg), sucrose (50 mg), L-proline (15 mg), polysorbate 80 (2 mg), and Water for Injection, USP.
5HOW SUPPLIED/STORAGE AND HANDLING
LIBTAYO (cemiplimab-rwlc) injection is a clear to slightly opalescent, colorless to pale yellow solution that may contain trace amounts of translucent to white particles. It is supplied in a carton containing 1 single-dose vial of:
- 350 mg/7 mL (50 mg/mL) (NDC 61755-008-01)
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Immune-Mediated Adverse Reactions
Advise patients that LIBTAYO can cause immune-mediated adverse reactions including the following
- Pneumonitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pneumonitis, including new or worsening symptoms of cough, chest pain, or shortness of breath.
- Colitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of colitis, including diarrhea, blood or mucus in stools, or severe abdominal pain.
- Hepatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of hepatitis.
- Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, hypophysitis, or type 1 diabetes mellitus.
- Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis.
- Dermatologic Adverse Reactions: Advise patients to contact their healthcare provider immediately if they develop a new rash.
- Other Immune-Mediated Adverse Reactions:
Infusion-Related Reactions
Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions
Complications of Allogeneic HSCT
Advise patients to contact their healthcare provider immediately if they develop signs or symptoms of post-allogeneic HSCT complications
Embryo-Fetal Toxicity
Advise females of reproductive potential that LIBTAYO can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy
Advise females of reproductive potential to use effective contraception during treatment and for at least 4 months after the last dose of LIBTAYO
Lactation
Advise female patients not to breastfeed while taking LIBTAYO and for at least 4 months after the last dose
7PRINCIPAL DISPLAY PANEL - 350 mg/7 mL Vial Carton
NDC 61755-008-01
LIBTAYO
350 mg/7 mL (50 mg/mL)
For Intravenous Infusion After Dilution
Discard unused portion.
Do not use vial if seal is broken or missing.
REGENERON
