The Role of Immunotherapy as a Potential Treatment in Locally Advanced BCC

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LIBTAYO® (cemiplimab-rwlc) is indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate. Please click here for full Prescribing Information.

Dr. Karl Lewis, Professor in the Division of Medical Oncology at the University of Colorado, discusses the evolving treatment strategy for locally advanced basal cell carcinoma (BCC) and the role of immunotherapy. This article was sponsored and developed by Regeneron in collaboration with Dr. Lewis.

Dr. Karl Lewis Professor in the Division of Medical Oncology at the University of Colorado

Dr. Karl Lewis

Professor in the Division of Medical Oncology at the University of Colorado

How often do you see advanced BCC in your practice?

In the United States, more than two million patients are diagnosed with BCC each year and the incidence rates continue to increase over time.1,2 In most cases, BCC can be caught early and cured.2 However, in ~20,000 patients, BCC can progress to an advanced stage where the cancer becomes more difficult to treat and is potentially life-threatening.2,3

While rare, I typically see advanced BCC cases a few times each year.

Why is it important to identify early on if a patient is at risk for advanced BCC?

As with any type of cancer, detecting BCC early is critical to be able to treat the tumor.2 Fortunately, most cases of BCC remain localized and are easily amenable to local intervention, such as excision.2 However, some patients may present with what seems like an innocuous tumor but could already have spread locally under the surface of the skin. In some cases, the disease may appear in compromising places anatomically, such as on or next to the orbit or the nose, making it more difficult to remove.1,2 In these instances, we need to evaluate other forms of treatment.

When are medical oncologists like yourself usually engaged as part of a multidisciplinary team (MDT) to treat someone with advanced BCC?

In some instances, I don’t see patients with advanced BCC until after surgery has been attempted. In some cases, patients may experience disfiguration in the absence of clear margins. In other cases, patients are referred to my practice by other physicians to discuss systemic therapy options as part of their initial work-up.

Advanced BCC is best managed in a multidisciplinary setting that consists of dermatologists, Mohs or head and neck surgeons, as well as radiation and medical oncologists, who can work together to develop the best treatment plan for a particular patient.2

In my experience, the involvement of an MDT can vary based on the referring physician. For cases of advanced BCC, I encourage physicians to involve oncologists early in the treatment process, and over time, I have seen this happen more frequently.

How has the treatment landscape for locally advanced BCC evolved in recent years?

Historically, treatment options for patients with locally advanced BCC have been limited to surgery or radiotherapy.2

Some patients with locally advanced BCC may be treated with surgical procedures but determining whether locally advanced BCC is fully resectable is often a challenge.2 If tumors are not completely excised, the risk of disease recurrence is high; alternatively, wide surgical margins can lead to severe disfigurement, loss of function and other detrimental effects.2

Systemic therapies, including hedgehog pathway inhibitors (HHIs), have changed the treatment paradigm for patients with locally advanced BCC.2 However, while HHIs may be effective for many advanced cases, some patients may discontinue HHI therapy due to progressive disease or adverse events and will require another treatment.2,4

In these cases, I believe immunotherapy can play an important role. Specifically, immune checkpoint inhibitors like LIBTAYO, which targets PD-1, may be appropriate in these cases.2

Where does LIBTAYO (cemiplimab-rwlc) fit in the treatment of locally advanced BCC?

In February 2021, LIBTAYO was approved by the U.S. Food and Drug Administration (FDA) as the first treatment indicated for patients with locally advanced BCC previously treated with an HHI or for whom an HHI is not appropriate.4 The approval was based on data from the pivotal Phase 2 trial which included patients with locally advanced BCC after treatment with HHIs.5

Important Safety Information
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-mediated adverse reactions usually occur during treatment, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Please see additional Important Safety Information throughout this article and click here for full Prescribing Information.

What is the recommended dosage for LIBTAYO?

The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity.5

Can you elaborate on the dataset that supports the use of LIBTAYO in locally advanced BCC?

LIBTAYO was approved by the FDA based on results from the pivotal, open-label, multicenter, Phase 2, nonrandomized study that included 132 patients, of whom 84 had locally advanced BCC that had progressed on HHI therapy, were intolerant of prior HHI therapy, or had not had an objective response after nine months on HHI therapy.5 Of these 84 patients, 75% of patients discontinued HHI therapy due to disease progression/lack of response and 25% discontinued treatment due to intolerance to HHI therapy.3 Treatment continued until progression of disease, unacceptable toxicity or completion of planned treatment.5

The study excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents within five years; history of solid organ transplant; prior treatment with anti–PD-1/PD-L1 therapy or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B or hepatitis C; or Eastern Cooperative Oncology Group Performance Status ≥2.5

The 84 patients with locally advanced BCC received LIBTAYO 350 mg every three weeks as an intravenous infusion for up to 93 weeks.5 Tumor response was assessed every nine weeks for the first 45 weeks of therapy and every 12 weeks thereafter.5 The primary endpoint was confirmed objective response rate (ORR) assessed by independent central review (ICR).5 Secondary endpoints included duration of response (DOR), complete response (CR) rate and safety and tolerability.3

Among the 84 patients with locally advanced BCC, the ORR was 29% (95% CI: 19%-40%), including a 23% partial response and 6% complete response.5 The median duration of follow up was 15.1 months for patients with laBCC.5 Furthermore, the DOR had not been reached (range: 2.1-21.4+ months) and 79.2% of patients had a DOR of six months or greater.5 The median time to response was 4.2 months (range: 2.1-13.4 months).5

Plus sign (+) denotes ongoing at last assessment

What was the safety profile for LIBTAYO in this pivotal trial?

The safety of LIBTAYO was evaluated in 132 patients with advanced BCC, including 84 patients with locally advanced BCC, in the Phase 2 trial.5

Serious adverse reactions (ARs) occurred in 32% of patients. Serious ARs that occurred in >1.5% (at least two patients) were urinary tract infection, colitis, acute kidney injury, adrenal insufficiency, anemia, infected neoplasm and somnolence.5 Fatal ARs occurred in 1.5% of patients who received LIBTAYO, including acute kidney injury and cachexia.5

LIBTAYO was permanently discontinued due to an AR in 13% of patients. Adverse reactions resulting in permanent discontinuation of LIBTAYO in >1.5% (at least two patients) were colitis and general physical health deterioration.5

Dosage delays of LIBTAYO due to an AR occurred in 34% of patients. ARs which required dosage delay in >2% of patients (at least three patients) included blood creatinine increased, diarrhea, colitis, fatigue, headache, pneumonitis and urinary tract infection.5

The most common ARs reported in at least 15% of patients were fatigue, musculoskeletal pain, diarrhea, rash, pruritus and upper respiratory tract infection.5 The most common Grade 3 or 4 ARs (>2%) were hypertension, colitis, fatigue, urinary tract infection, pneumonia, increased blood pressure, hypokalemia and visual impairment. The most common (>3%) laboratory abnormality worsening from baseline to Grade 3 or 4 was hyponatremia.5 The adverse reactions that occurred in ≥10% of patients receiving LIBTAYO in Study 1620 can be seen below.

Safety profile of LIBTAYO in Study 16205*

Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03.

†Fatigue is a composite term that includes fatigue, asthenia, and malaise.5

‡Musculoskeletal pain is a composite term that includes arthralgia, back pain, myalgia, pain in extremity, musculoskeletal pain, neck pain, musculoskeletal stiffness, musculoskeletal chest pain, musculoskeletal discomfort, and spinal pain.5

§Rash is a composite term that includes rash maculo-papular, rash, dermatitis, dermatitis acneiform, erythema, rash pruritic, dermatitis bullous, dyshidrotic eczema, pemphigoid, rash erythematous, and urticaria.5

||Upper respiratory tract infection is a composite term that includes upper respiratory tract infection, nasopharyngitis, rhinitis, sinusitis, pharyngitis, respiratory tract infection, and viral upper respiratory tract infection.5

¶Dyspnea is a composite term that includes dyspnea and dyspnea exertional.5

#Hypertension is a composite term that includes hypertension and hypertensive crisis.5

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-mediated adverse reactions usually occur during treatment, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1/PD-L1–blocking antibodies. The definition of immune-mediated adverse reactions included the required use of systemic corticosteroids or other immunosuppressants and the absence of a clear alternate etiology. Monitor closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

No dose reduction for LIBTAYO is recommended. In general, withhold LIBTAYO for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue LIBTAYO for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated adverse reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to 10 mg or less of prednisone equivalent per day within 12 weeks of initiating steroids.

Withhold or permanently discontinue LIBTAYO depending on severity. In general, if LIBTAYO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroids.

Immune-mediated pneumonitis: LIBTAYO can cause immune-mediated pneumonitis. In patients treated with other PD-1/PD-L1–blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.2% (26/810) of patients receiving LIBTAYO, including Grade 4 (0.5%), Grade 3 (0.5%), and Grade 2 (2.1%). Pneumonitis led to permanent discontinuation in 1.4% of patients and withholding of LIBTAYO in 2.1% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 58% of the 26 patients. Of the 17 patients in whom LIBTAYO was withheld, 9 reinitiated after symptom improvement; of these, 3/9 (33%) had recurrence of pneumonitis. Withhold LIBTAYO for Grade 2, and permanently discontinue for Grade 3 or 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

Immune-mediated colitis: LIBTAYO can cause immune-mediated colitis. The primary component of immune-mediated colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis treated with PD-1/PD-L1–blocking antibodies. In cases of corticosteroid-refractory immune-mediated colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2.2% (18/810) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (1.1%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.5% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 39% of the 18 patients. Of the 12 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 3/4 (75%) had recurrence. Withhold LIBTAYO for Grade 2 or 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2% (16/810) of patients receiving LIBTAYO, including fatal (0.1%), Grade 4 (0.1%), Grade 3 (1.4%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.2% of patients and withholding of LIBTAYO in 0.5% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 19% (3/16) of these patients. Hepatitis resolved in 50% of the 16 patients. Of the 5 patients in whom LIBTAYO was withheld, 3 reinitiated LIBTAYO after symptom improvement; of these, none had recurrence.

For hepatitis with no tumor involvement of the liver: Withhold LIBTAYO if AST or ALT increases to more than 3 and up to 8 times the upper limit of normal (ULN) or if total bilirubin increases to more than 1.5 and up to 3 times the ULN. Permanently discontinue LIBTAYO if AST or ALT increases to more than 8 times the ULN or total bilirubin increases to more than 3 times the ULN.

For hepatitis with tumor involvement of the liver: Withhold LIBTAYO if baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN. Also, withhold LIBTAYO if baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN. Permanently discontinue LIBTAYO if AST or ALT increases to more than 10 times ULN or if total bilirubin increases to more than 3 times ULN. If AST and ALT are less than or equal to ULN at baseline, withhold or permanently discontinue LIBTAYO based on recommendations for hepatitis with no liver involvement.

Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

Immune-mediated endocrinopathies: For Grade 3 or 4 endocrinopathies, withhold until clinically stable or permanently discontinue depending on severity.

  • Adrenal insufficiency: LIBTAYO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold LIBTAYO depending on severity. Adrenal insufficiency occurred in 0.4% (3/810) of patients receiving LIBTAYO, including Grade 3 (0.4%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (0.1%) patient. LIBTAYO was not withheld in any patient due to adrenal insufficiency. Systemic corticosteroids were required in all patients with adrenal insufficiency; of these, 67% (2/3) remained on systemic corticosteroids. Adrenal insufficiency had not resolved in any patient at the time of data cutoff
  • Hypophysitis: LIBTAYO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated. Withhold or permanently discontinue depending on severity. Hypophysitis occurred in 0.4% (3/810) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.1%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (0.1%) patient and withholding of LIBTAYO in 1 (0.1%) patient. Systemic corticosteroids were required in 67% (2/3) of patients with hypophysitis. Hypophysitis had not resolved in any patient at the time of data cutoff
  • Thyroid disorders: LIBTAYO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement or medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue LIBTAYO depending on severity
  • Thyroiditis: Thyroiditis occurred in 0.6% (5/810) of patients receiving LIBTAYO, including Grade 2 (0.2%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis had not resolved in any patient at the time of data cutoff. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported
  • Hyperthyroidism: Hyperthyroidism occurred in 3.2% (26/810) of patients receiving LIBTAYO, including Grade 2 (0.9%). No patient discontinued treatment and LIBTAYO was withheld in 0.5% of patients due to hyperthyroidism. Systemic corticosteroids were required in 3.8% (1/26) of patients. Hyperthyroidism resolved in 50% of 26 patients. Of the 4 patients in whom LIBTAYO was withheld for hyperthyroidism, 2 patients reinitiated LIBTAYO after symptom improvement; of these, none had recurrence of hyperthyroidism
  • Hypothyroidism: Hypothyroidism occurred in 7% (60/810) of patients receiving LIBTAYO, including Grade 2 (6%).Hypothyroidism led to permanent discontinuation of LIBTAYO in 1 (0.1%) patient. Hypothyroidism led to withholding of LIBTAYO in 1.1% of patients. Systemic corticosteroids were not required in any patient with hypothyroidism. Hypothyroidism resolved in 8.3% of the 60 patients. Majority of the patients with hypothyroidism required long-term thyroid hormone replacement. Of the 9 patients in whom LIBTAYO was withheld for hypothyroidism, 1 reinitiated LIBTAYO after symptom improvement; 1 required ongoing hormone replacement therapy
  • Type 1 diabetes mellitus, which can present with diabetic ketoacidosis: Monitor for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold LIBTAYO depending on severity. Type 1 diabetes mellitus occurred in 0.1% (1/810) of patients, including Grade 4 (0.1%).No patient discontinued treatment due to type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients

Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.6% (5/810) of patients receiving LIBTAYO, including fatal (0.1%), Grade 3 (0.1%), and Grade 2 (0.4%). Nephritis led to permanent discontinuation in 0.1% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 80% of the 5 patients. Of the 3 patients in whom LIBTAYO was withheld, 2 reinitiated LIBTAYO after symptom improvement; of these, none had recurrence. Withhold LIBTAYO for Grade 2 or 3 increased blood creatinine, and permanently discontinue for Grade 4 increased blood creatinine. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

Immune-mediated dermatologic adverse reactions: LIBTAYO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1–blocking antibodies. Immune-mediated dermatologic adverse reactions occurred in 1.6% (13/810) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.6%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.1% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 69% of the 13 patients. Of the 11 patients in whom LIBTAYO was withheld for dermatologic adverse reactions, 7 reinitiated LIBTAYO after symptom improvement; of these, 43% (3/7) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Withhold LIBTAYO for suspected SJS, TEN, or DRESS. Permanently discontinue LIBTAYO for confirmed SJS, TEN, or DRESS. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids.

Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 810 patients who received LIBTAYO or were reported with the use of other PD-1/PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions.

  • Cardiac/vascular: Myocarditis, pericarditis, and vasculitis. Permanently discontinue for Grades 2, 3, or 4 myocarditis
  • Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy. Withhold for Grade 2 neurological toxicities and permanently discontinue for Grades 3 or 4 neurological toxicities. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Permanently discontinue if no complete or partial resolution within 12 weeks of initiating steroids or inability to reduce prednisone to less than 10 mg per day (or equivalent) within 12 weeks of initiating steroids
  • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
  • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis, stomatitis
  • Musculoskeletal and connective tissue: Myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
  • Endocrine: Hypoparathyroidism
  • Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection

Infusion-related reactions

Severe infusion-related reactions (Grade 3) occurred in 0.1% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. The most common symptoms of infusion-related reaction were nausea, pyrexia, rash, and dyspnea. Interrupt or slow the rate of infusion for Grade 1 or 2, and permanently discontinue for Grade 3 or 4.

Complications of allogeneic HSCT

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1–blocking antibody prior to or after an allogeneic HSCT.

Embryo-fetal toxicity

LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.

ADVERSE REACTIONS

  • In the pooled safety analysis of 810 patients, the most common adverse reactions (≥15%) with LIBTAYO were musculoskeletal pain, fatigue, rash, and diarrhea
  • In the pooled safety analysis of 810 patients, the most common Grade 3-4 laboratory abnormalities (≥2%) with LIBTAYO were lymphopenia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia

USE IN SPECIFIC POPULATIONS

  • Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO
  • Females and males of reproductive potential: Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO

Please click here for full Prescribing Information.

INDICATIONS AND USAGE

LIBTAYO is indicated for the treatment of patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate.

References

  1. Harris, L. Basal Cell Carcinoma: A Pharmacist’s Guide. US Pharmacist 2019 Aug;44(8):29-35.
  2. Migden, M. et al. Emerging trends in the treatment of advanced basal cell carcinoma. Cancer Treatment Reviews 2017; 64(2018):1-10.
  3. Data on file. Regeneron Pharmaceuticals, Inc.
  4. Stratigos, A J. et. al. Cemiplimab in locally advanced basal cell carcinoma after hedgehog inhibitor therapy: an open-label, multi-centre, single-arm, phase 2 trial. The Lancet Oncology; 22(2021):1-10.
  5. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. https://www.regeneron.com/sites/default/files/LIBTAYO_FPI.pdf. Accessed on April 7, 2022.

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