Cemiplimab

Class
Targeted therapy
Subclass
Anti-PD-1 monoclonal antibodies
Substance name
Cemiplimab, cemiplimab-rwlc
Brand names
Libtayo®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Basal cell carcinoma • Locally advanced or metastatic, if hedgehog pathway inhibitors is ineffective or contraindicated
•
350 mg IV q3 weeks until disease progression, unacceptable toxicity, or up to 24 months
Administered over 30 minutes.
Cutaneous SCC • Locally advanced or metastatic
•
350 mg IV q3 weeks until disease progression, unacceptable toxicity, or up to 24 months
Administered over 30 minutes.
Non-small cell lung cancer without EGFR mutation, ALK gene fusion, NPM-ALK fusion protein, ROS1 gene fusion, ROS1 fusion protein • Locally advanced or metastatic
•
350 mg IV q3 weeks until disease progression or unacceptable toxicity
Administered over 30 minutes. Administered in combination with platinum‐based chemotherapy.
Non-small cell lung cancer without EGFR mutation, ALK gene fusion, NPM-ALK fusion protein, ROS1 gene fusion, ROS1 fusion protein • Locally advanced or metastatic, high PD-L1 expression
•
350 mg IV q3 weeks until disease progression or unacceptable toxicity
Administered over 30 minutes.
Cervical cancer • Metastatic or recurrent • Off-label
•
350 mg IV q3 weeks for up to 96 weeks or unacceptable toxicity
Administered over 30 minutes.
Indications for use
Labeled indications
Adults
•
Treatment of basal cell carcinoma (locally advanced or metastatic), if hedgehog pathway inhibitors is ineffective or contraindicated
•
Treatment of cutaneous SCC (locally advanced or metastatic)
•
Treatment of non-small cell lung cancer without EGFR mutation, ALK gene fusion, NPM-ALK fusion protein, ROS1 gene fusion, ROS1 fusion protein (locally advanced or metastatic)
•
Treatment of non-small cell lung cancer without EGFR mutation, ALK gene fusion, NPM-ALK fusion protein, ROS1 gene fusion, ROS1 fusion protein (locally advanced or metastatic, high PD-L1 expression)
Off-label indications
Adults
•
Treatment of cervical cancer (metastatic or recurrent)
Safety risks
Contraindications
Hypersensitivity to cemiplimab or its components
Warnings and precautions
GvHD, hepatic veno-occlusive disease
•
Maintain a high level of suspicion, as serious transplant-related complications, including graft-versus-host-disease, hepatic veno-occlusive disease, and corticosteroid-requiring febrile syndrome, can occur in patients receiving allogeneic HSCT before or after being treated with a PD-1/PD-L1 blocking antibody.
Immune-related adverse events
•
Maintain a high level of suspicion, as cemiplimab has been associated with severe and potentially fatal immune-mediated complications, including pneumonitis, colitis, hepatitis, adrenal insufficiency, hypophysitis, thyroid disorders, T1DM, nephritis, dermatitis, solid organ transplant rejection, myocarditis, pericarditis, vasculitis, and other immune-mediated adverse reactions. Obtain liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue cemiplimab in the case of grade 2-4 adverse reactions, depending on the severity, and administer systemic corticosteroids until improvement to grade ≤ 1.
Infusion-related reactions
•
Maintain a high level of suspicion, as cemiplimab has been associated with serious and life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt or reduce the infusion rate for grade 1-2 reactions. Discontinue permanently for grade 3-4 reactions.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available. Monitor serum creatinine. Monitor for acute kidney injury.
Renal replacement therapy
Any modality
•
No guidance available. Monitor serum creatinine. Monitor for acute kidney injury.
Hepatic impairment
Any severity
•
No guidance available. Monitor liver function tests. Cemiplimab has not been studied in patients with severe hepatic impairment.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in humans. Verify pregnancy status in females of reproductive potential before initiating treatment. Advise using effective contraception during treatment and for at least 4 months after the last dose.
Breastfeeding
Halt breastfeeding temporarily.
•
Advise females not to breastfeed during treatment and for at least 4 months after the last dose.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Acute kidney injury, anemia, cellulitis, hypertension, hypothyroidism, peripheral neuropathy, pneumonia, abdominal pain, bleeding, constipation, cough, diarrhea, dizziness, dyspnea, fatigue, hair loss, headache, insomnia, itching, loss of appetite, musculoskeletal pain, nausea, skin rash, vomiting, weight loss, urinary tract infections, upper respiratory tract infections
Common 1-10%
•
Actinic keratosis, colitis, ↓ WBC count, ↓ blood lymphocyte count, ↓ blood neutrophil count, ↓ platelet count, ↓ serum albumin, ↓ serum calcium, ↓ serum phosphate, ↓ serum potassium, ↓ serum sodium, hepatitis, hyperthyroidism, ↑ INR, ↑ blood glucose, ↑ liver enzymes, ↑ serum ALP, ↑ serum calcium, ↑ serum magnesium, ↑ serum potassium, ↑ serum sodium, peripheral edema, pneumonitis, ↑PT
Uncommon < 1%
•
Adrenal insufficiency, hypophysitis, nephritis, thyroiditis
Unknown frequency
•
Acute respiratory distress syndrome, acute mesenteric ischemia, acute pancreatitis, aplastic anemia, arthritis, aseptic meningitis, cachexia, complex regional pain syndrome, DRESS syndrome, demyelinating lesions, dermatitis, dermatomyositis, diabetic ketoacidosis, drug-induced liver injury, encephalitis, eosinophilic fasciitis, erythema multiforme, erythroderma, Guillain-Barré syndrome, graft-versus-host disease, hemolytic anemia, hemophagocytic lymphohistiocytosis, hepatic veno-occlusive disease, hypoparathyroidism, hypopituitarism, interstitial lung disease, immune thrombocytopenia, infusion-related reactions, iritis, Lambert-Eaton myasthenic syndrome, meningitis, myelitis, myocarditis, myositis, neuropathy, pemphigoid, pericarditis, polymyalgia rheumatica, polymyositis, pulmonary hemorrhage, asthenia, fever, visual disturbances, rhabdomyolysis, sepsis, Stevens-Johnson syndrome, systemic inflammatory response syndrome, toxic epidermal necrolysis, transplant rejection, uveitis, vasculitis, vogt-Koyanagi-Harada syndrome
Interactions
Drug(s)
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