Living With Advanced Basal Cell Carcinoma: A Patient's Treatment Journey

Dr Todd Schlesinger and Donna, a real Libtayo patient, are paid spokespeople of Regeneron.

Learn about advanced basal cell carcinoma (BCC) and the importance of multidisciplinary care when treating patients with BCC, as this webinar delves into a potential treatment option and supportive clinical trial data, including a personal account of someone living with locally advanced BCC.

The objectives of this webinar are to:

• Identify patients who are at high risk for developing advanced BCC.
• Discuss the importance of a multidisciplinary approach in the management of patients with advanced BCC.
• Review the considerations for systemic therapy in patients with advanced BCC.
• Describe the clinical and safety data of a systemic therapy option in advanced BCC.
• Convey the firsthand experiences of Donna, who is a patient living with advanced BCC, and how her experiences have involved multidisciplinary care and treatment with systemic therapy.

Please see full Prescribing Information.

Dr Schlesinger: Hello and welcome! Thank you for joining us today for this presentation, “Living with Advanced Basal Cell Carcinoma: A Patient’s Treatment Journey.” I’m Dr Schlesinger, and I’m a dermatologist at the Dermatology and Laser Center of Charleston. It’s a pleasure to speak with you today. During this section, we will be discussing advanced basal cell carcinoma and the importance of the multidisciplinary care. We’ll also discuss a potential treatment option and the clinical trial data. 

Additionally, we have the opportunity to hear directly from someone living with locally advanced basal cell carcinoma [BCC]. Donna, would you mind starting us off today by telling us a little bit about yourself?

Donna: Sure. Hi, I’m Donna, and I live in New Jersey with my husband. I was diagnosed with local advanced BCC in November of 2010. For the past 12 or so years, I have worked hard to find the right treatment and care. Today, I will be sharing my treatment journey with advanced BCC, hoping that I can provide encouragement, positivity, and strength to others caring for patients with advanced BCC.

Dr Schlesinger: Thank you, Donna! We look forward to hearing more about it.

This program is sponsored by Regeneron Pharmaceuticals, Inc. There is no continuing medical education, or CME, credits available. The speakers, myself and Donna, are paid consultants of Regeneron, and the content is developed by Regeneron.

The objectives of today’s presentation include:

• Identifying patients at high risk for developing advanced basal cell carcinoma.
• Reviewing the importance of a multidisciplinary approach in the management of patients with advanced BCC.
• Reviewing the considerations for systemic therapy in patients with advanced BCC.
• And reviewing the clinical and safety data of a systemic therapy option in advanced basal cell carcinoma.
• And, most importantly, hearing firsthand experiences from Donna, who is a patient living with advanced BCC, corresponding to the sections that are mentioned above.

Dr Schlesinger: Basal cell carcinoma is the most common form of nonmelanoma skin cancer, accounting for approximately 67% of all nonmelanoma skin cancer cases. Cutaneous squamous cell carcinoma accounts for approximately a third of nonmelanoma skin cancer cases. More than 2 million patients are diagnosed with BCC every year in the United States.

Progression to advanced BCC can cause significant invasion of surrounding tissue, or more rarely, nodal or distant metastases. Each year in the United States, over 20,000 patients progress to advanced BCC and may no longer be amenable to surgery or radiation. Advanced BCC impacts patients across numerous domains, including daily activities, emotional well-being, and social and leisure activities. While there’s no formal definition for locally advanced basal cell carcinoma, it’s often used to describe large or aggressive, recurrent, or deeply invasive tumors.

Dr Schlesinger: There are several risk factors associated with BCC recurrence in patients with localized disease. These include various features of the tumor, such as its size, location, and pathology, as well as the history of the tumor and other factors, such as immunosuppression. Patients with even a single risk factor are deemed high-risk for BCC recurrence. While most patients with BCC benefit from surgical interventions, incomplete surgical resection can increase the risk of recurrence. And incomplete surgical resection has been reported to increase the likelihood of disease recurrence up to 27%. 

Let’s discuss the role of the multidisciplinary team in the management of advanced basal cell carcinoma. The multidisciplinary approach is key to treating advanced BCC. There are several guidelines you see here, but per guidelines from the American Academy of Dermatology as well as the popular NCCN Clinical Practice Guidelines in Oncology, also known as the NCCN Guidelines®, management of patients with advanced BCC requires a consultation with a multidisciplinary team with specific expertise in BCC, such as a surgical, medical, or radiation oncologist, a head and neck surgeon, plastic surgeon, or, such as myself, a dermatologist who specializes in BCC.

We’ll go over the role of the multidisciplinary team in evaluating the treatment options and managing systemic therapies in patients with advanced BCC.

Dr Schlesinger: So, I’d like to pause for a moment and talk to Donna about her advanced BCC diagnosis and access to a multidisciplinary team during her treatment journey. 

Donna, can you tell us a little bit more about your treatment experience, your diagnosis experience?

Donna: Sure. I was diagnosed in 2010 with locally advanced basal cell carcinoma, and even though I tend to see the positives, my life has changed a lot. The diagnosis came as quite a shock. I hadn’t experienced any symptoms, or at least none that I was aware of.

During an appointment with my son’s dermatologist, his doctor noticed that I had some bumps around my eyes and asked if I would allow her to perform a biopsy. Of course I said yes, never thinking it would ever amount to anything. I’ve never heard of a form of skin cancer called locally advanced BCC. I didn’t think it was a big deal at the time, until I was diagnosed a few weeks later. Talk about living in the dark!

Once I learned more and started to go through treatment after treatment, it really was harsh. There have been many ups and downs, but after looking back on everything, I still feel blessed.

Dr Schlesinger: So, given all that, how could your doctor support you more at the initial diagnosis? 

Donna: Unlike with other types of cancers, patients with BCCs are not given a clear stage prognosis. I struggled with that unknown and wished that my doctor explained the complexity of this disease to me. 

Dr Schlesinger: That makes so much sense to me. After your diagnosis, were you cared for by a multidisciplinary team? If so, how was that experience?

Donna: After I was diagnosed, my dermatologist felt it was best to refer me to a more diverse care team, which included a Mohs surgeon, a dermatological oncologist, and other specialists. I call them my medical family. Through this care team, I received a variety of procedures and treatments. My multidisciplinary team entered me into a clinical trial for a hedgehog inhibitor, which is an oral systemic therapy.

Dr Schlesinger: Well, I’m glad to know that you had support from an MDT – multidisciplinary team – and they were able to determine an appropriate treatment plan for you. Thank you so much for sharing.

So, we’ll continue our discussion now on the treatment of advanced basal cell carcinoma. Once a patient with advanced BCC is no longer a candidate for surgery or radiation, systemic therapies can play a critical role in their management. There are various considerations for systemic therapies, which include tumor characteristics, patient characteristics, as well as their treatment history.

So, these are some of the things that we have to consider. Tumor characteristics such as size, the level of invasion of the tumor, potential for deformity or morbidity, how much is that surgery going to affect somebody if you remove that large tumor. The growth pattern is important, is it an aggressive growth basal cell carcinoma, or even some cases, multiple basal cell carcinoma tumors.

We also have to think about patient characteristics, which include the patient’s age, do they have any comorbidities, what’s their performance status, and what are their preferences? It’s so important to think about and talk to our patients about what things they might prefer, what treatments they might prefer.

And then treatment history, which would include multiple recurrences possibly, whether the patient’s had radiotherapy before or prior surgery. So, these are the things we’ll think about.

Dr Schlesinger: So, a multidiscliplinary treatment plan is recommended for patients with advanced basal cell carcinoma who discontinue or are inappropriate for hedgehog pathway inhibitor therapy. So, many patients that are diagnosed with advanced basal cell carcinoma end up on a hedgehog pathway inhibitor treatment. And of those patients that are prescribed it, patients may experience various outcomes. They may have a dose adjustment or a treatment holiday, which may be related to the adverse events they experience. They may also experience discontinuation – they may have discontinuation due to intolerance, due to – maybe the patient completed treatment or that their disease progressed. 

So, when hedgehog pathways are an important part of the treatment regimen, 90% of patients ultimately discontinue that therapy. Some patients are also deemed by their clinician or doctor inappropriate for hedgehog pathway inhibitor therapy, and the clinician judgement becomes very important there.

The big gap in care is that only 1 in 10 patients who actually discontinue a hedgehog pathway inhibitor, for whatever reason that is, go on to do another treatment. So, there’s a big gap in care. It’s something we have to try to help with here. So, again, the multidisciplinary team is very important. 

Dr Schlesinger: So, Donna, you mentioned that you were treated with a hedgehog pathway inhibitor. Can you tell us a little bit more about that treatment experience?

Donna: Yes. I was enrolled in a hedgehog inhibitor clinical trial, but after four-and-a-half years, my doctors decided to take me off the HHI. When I could no longer handle the hedgehog inhibitor, I was very scared for my future, what it held for me and my family, because I really didn’t know what was going to happen next.

As I started on the journey of finding a treatment option after the hedgehog inhibitor, the basal cell carcinoma came back with a vengeance. When my medical team heard about another clinical trial for advanced BCC, they called and told me about LIBTAYO (cemiplimab-rwlc).

Dr Schlesinger: Thank you, Donna, for sharing that experience with us.

So, Donna mentioned the treatment options after hedgehog pathway inhibitor therapy, and I’d like to take this opportunity to discuss LIBTAYO, or cemiplimab-rwlc, as a systemic therapy option for appropriate patients with advanced BCC. We’re now going to go over the clinical and safety profile of LIBTAYO, which is a programmed death inhibitor-1, or PD-1 inhibitor, indicated for the treatment of patients with locally advanced or metastatic basal cell carcinoma, also known as laBCC or mBCC, who have been previously treated with a hedgehog pathway inhibitor (HHI) or for whom that treatment is not appropriate; metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation.

LIBTAYO has over 8 years of clinical treatment experience. And it’s the number one most prescribed immunotherapy by oncologists for patients with advanced BCC or advanced cutaneous squamous cell carcinoma. Over 20,000 patients have been treated with LIBTAYO across all of its FDA-approved indications.

Dr Schlesinger: We’ll now talk a little bit about the mechanism of action of LIBTAYO. T cells normally target abnormal cells, including cancer cells, in order to attack and kill them. Cancer cells can avoid being attacked by T cells by using the PD-1 pathway. T-cell inactivation can result from the interaction of the PD-1 receptor on T cells with its ligands, the programmed death-ligand 1, or PD-L1, and the programmed death-ligand 2, or PD-L2, that’s expressed on tumor cells.

This slide provides an overview of the mechanism of action of LIBTAYO. LIBTAYO acts by blocking the PD-1 pathway. LIBTAYO binds to PD-1 on T cells, blocking its interaction with PD-L1 and PD-L2 expressed on tumor cells. So, this blockade helps to reactivate T-cell receptor signaling, restoring antitumor activity.

Narrator: 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.
• Withhold or permanently discontinue LIBTAYO depending on severity of the adverse reaction (see Section 2 Dosage and Administration in the accompanying Full Prescribing Information). 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. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (eg, endocrinopathies and dermatologic reactions) are discussed below. 
• The incidence and severity of immune-mediated adverse reactions were similar when LIBTAYO was administered as a single agent or in combination with chemotherapy.

Dr Schlesinger: Let’s take a look at the clinical trial design.

The efficacy and safety of LIBTAYO were evaluated in Study 1620 in 84 patients with locally advanced BCC and 54 patients with metastatic BCC who had progressed on hedgehog pathway inhibitor therapy, had not had an objective response after 9 months on hedgehog pathway inhibitor therapy, or were intolerant to a prior hedgehog pathway inhibitor therapy. This study was an open-label, multicenter, nonrandomized study. The study excluded patients with autoimmune disease that required systemic therapy with immunosuppressant agents within 5 years; prior treatment with anti–PD-1/PD-L1 therapy or other immune checkpoint inhibitor therapy; history of solid organ transplant; infection with HIV, hepatitis B virus, or hepatitis C virus; or had an ECOG performance status of ≥2. 

Patients received LIBTAYO 350 mg every 3 weeks for up to 93 weeks of treatment. Treatment continued until disease progression, unacceptable toxicity, or completion of planned treatment. Tumor assessments were performed every 9 weeks during cycles 1 through 5 and every 12 weeks during cycles 6 through 9.

The primary efficacy endpoint was confirmed objective response rate (ORR) by independent central review (ICR), and the objective response rate is the complete responders plus the partial responders.

For patients without externally visible lesions, the objective response rate was determined by RECIST 1.1, and for patients with externally visible target lesions, the ORR was determined by a composite endpoint that integrated the independent central review assessments of radiologic data, using RECIST 1.1, and digital medical photography, which uses the WHO Criteria.

Dr Schlesinger: The secondary endpoints included duration of response, the complete response rate, as well as safety and tolerability.

LIBTAYO demonstrated clinically meaningful and durable responses in locally advanced basal cell carcinoma. So, in those patients with locally advanced BCC, who numbered 84 in the 1620 study, the objective response rate was 32%, comprised of 25% partial response and 7% complete response.

The time to response was a median of 4.3 months, which helps me talk to my patients about when they can expect to see response on their tumors. The observed duration of response talks to us about what percentage of those patients that respond will still have a response at any given time point, and as you can see here, 85% of the patients that got a response had a duration of response of 6 or greater months.

Now below you’ll see on the left-hand side an exploratory subgroup analysis of the overall response rates by reason for prior hedgehog pathway inhibitor discontinuation. Please note that this analysis did not have enough power for our hypothesis test and no firm conclusions can be made. So, you’ll see that the overall response rate was similar whether a patient had progression or lack of response on the prior hedgehog pathway inhibitor or they were intolerant to a prior hedgehog pathway inhibitor before entering the 1620 study.

Warnings and Precautions for LIBTAYO include severe and fatal immune-mediated adverse reactions, such as immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplant; and embryo-fetal toxicity. Monitor for symptoms and signs of immune-mediated adverse reactions.

See additional Important Safety Information throughout this presentation and in Section 5 of the accompanying full Prescribing Information for more information on Warnings and Precautions.

Dr Schlesinger: 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 more than 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 Grade 4 adverse reactions occurring in >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.

Dr Schlesinger: Let us return to Donna and learn more about her introduction to LIBTAYO. Donna, how were you introduced to LIBTAYO?

Donna: When other treatment options no longer worked for me, my doctor called and informed me about LIBTAYO. My doctor said LIBTAYO can help my body’s immune system fight and kill cancer cells. My doctor also informed me that LIBTAYO can cause your immune system to attack normal organs and tissues in any area of the body and can affect the way that they work.

Prior to starting LIBTAYO, my doctor and I discussed the potential risks and side effects of LIBTAYO, including those that can be severe or life-threatening. We went over the risks and the benefits, and together we decided it would be an appropriate option for me.

Dr Schlesinger: Let’s go over some cases from the clinical trial. This is an example of a patient with locally advanced BCC from the 1620 study. As you can see, this is a 66-year-old patient with locally advanced basal cell carcinoma who had a right cranial lesion. You can see at screening what the tumor looked like with ulceration, after 9 weeks somewhat smaller, and after 101 weeks it sort of looks like a scar at this point after that much time. The patient had discontinued prior vismodegib due to intolerance. So, this is a best response for this patient was a partial response, and their time to response was a little bit faster than what you might glean from the median time to response of 2.1 months. And the duration of response was 29.9+ months, which indicates this patient was continuing to have ongoing therapy in response to the time of data cutoff. 

This patient is another example of a patient with locally advanced BCC from Study 1620. This is a 79-year-old patient with locally advanced BCC on the right auricular area. You can see this is an example from the 25% of the patients with locally advanced basal cell carcinoma who had a partial response in the Study 1620. This lesion involves, really it’s overtaken the entire ear and it’s an ulcerated lesion and underneath it you can see some tissue structures that are exposed now. After 18 weeks, you see improvement, a lot of improvement here, the skin has restored, you can see the hair is back there as well. And then after 104 weeks, looks like a scar again to me, I don’t see any visible tumor there, so… This patient discontinued prior vismodegib due to disease progression, and you can see that this patient’s clinical outcome best response was partial response. Their time to response was 4.2 month, which aligns very well with the median time to response from the study. And the duration of response was 32.4+ months, indicating ongoing response at the time of data cutoff.    

Narrator: 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 2.6% (33/1281) of patients receiving LIBTAYO, including Grade 4 (0.3%), Grade 3 (0.6%), and Grade 2 (1.6%). Pneumonitis led to permanent discontinuation in 1.3% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was withheld, 10 reinitiated after symptom improvement; of these, 4/10 (40%) had recurrence of pneumonitis.

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% (25/1281) patients receiving LIBTAYO, including Grade 3 (0.8%) and Grade 2 (0.9%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.2% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 56% of the 25 patients. Of the 16 patients in whom LIBTAYO was withheld, 6 reinitiated LIBTAYO after symptom improvement; of these, 4/6 (67%) had recurrence.

Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.4% (31/1281) patients receiving LIBTAYO, including fatal (<0.1%), Grade 4 (0.3%), Grade 3 (1.6%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 0.7% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 13% (4/31) of these patients. Hepatitis resolved in 39% of the 31 patients. Of the 9 patients in whom LIBTAYO was withheld, 5 reinitiated LIBTAYO after symptom improvement; of these, 1/5 (20%) had recurrence.

Dr Schlesinger: So, we’ll talk about another case here of a patient with locally advanced basal cell carcinoma, again from the 1620 study. And this is a right nasal cavity lesion. So we start to see a little bit of similarity from these cases that at screening this patient had a large, ulcerated tumor on the right side of their nose. It looks like from the scarring that I see that the patient probably had prior treatment, possibly including radiation. This patient discontinued prior vismodegib due to disease progression. And you can see the clinical outcome for this patient was a partial response. They had a time to response of 8.2 months, which is a little longer than the median time to response noted in the study. But the duration of response was 4.8 months. So this patient actually progressed with their tumor after a period of time. You can see after 32 weeks, 92 weeks the response you would get. And it made the tumor smaller and improved the tissue around it, so that’s something that we look for as a response to our patients. 

Here's another patient with locally advanced basal cell carcinoma, another example of the folks from the study. This is an example of the 7% of patients with locally advanced basal cell carcinoma who happened to have a complete response in 1620. So individual patient responses, of course, may vary, but you can see on the left-hand side of the screen the screening photograph. This is a tumor very near the eye, and it’s ulcerated, it has typical characteristics of locally advanced basal cell carcinoma. And on this patient happened to get a complete response, which means there was a biopsy showing that there wasn’t a tumor there and maybe other factors as well showing a complete response. The time to response in this patient was 4.2 months, and the duration of response was 23.8+ months, indicating ongoing response at the time of data cutoff.

Narrator: Immune-mediated endocrinopathies:

• 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 0.5% (6/1281) of patients receiving LIBTAYO, including Grade 3 (0.5%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient. LIBTAYO was withheld in 1 (<0.1%) patient due to adrenal insufficiency and not reinitiated. Systemic corticosteroids were required in 83% (5/6) patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency had resolved in 17% of the 6 patients.
• 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 0.5% (7/1281) patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.3%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient and withholding of LIBTAYO in 2 (0.2%) patients. Systemic corticosteroids were required in 86% (6/7) patients with hypophysitis. Hypophysitis resolved in 14% of the 7 patients. Of the 2 patients in whom LIBTAYO was withheld for hypophysitis, none of the patients reinitiated.
• 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% (8/1281) patients receiving LIBTAYO, including Grade 2 (0.3%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 (<0.1%) patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis resolved in 13% of the 8 patients. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported.
• Hyperthyroidism: Hyperthyroidism occurred in 3% (39/1281) patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (0.9%). No patient discontinued treatment, and LIBTAYO was withheld in 7 (0.5%) patients due to hyperthyroidism. Systemic corticosteroids were required in 8% (3/39) patients. Hyperthyroidism resolved in 56% of 39 patients. Of the 7 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% (87/1281) patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (6%). Hypothyroidism led to permanent discontinuation of LIBTAYO in 3 (0.2%) patients. Hypothyroidism led to withholding of LIBTAYO in 9 (0.7%) patients. Systemic corticosteroids were required in 1.1% (1/87) patients with hypothyroidism. Hypothyroidism resolved in 6% of the 87 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 and did not have recurrence of hypothyroidism.
• 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% (1/1281) patients (Grade 4). No patient discontinued treatment due to Type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients; treatment was reinitiated after symptom improvement. Patient received long-term insulin therapy. 

Dr Schlesinger: So LIBTAYO has straightforward dosing. There is no PD-L1 or tumor mutational burden testing that’s required before starting LIBTAYO in advanced basal cell carcinoma or advanced cutaneous squamous cell carcinoma. 

LIBTAYO is administered as a 350 mg injection via IV, it’s an infusion that’s given every 3 weeks over 30 minutes. Treatment is to be continued until disease progression, unacceptable toxicity, or up to 24 months. Please note that the liquid formulation of LIBTAYO dose does not require reconstitution.

Narrator: Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.7% (9/1281) patients receiving LIBTAYO, including fatal (<0.1%), Grade 3 (<0.1%), and Grade 2 (0.5%). Nephritis led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 78% of the 9 patients. Of the 5 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 1/4 (25%) had recurrence.

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 1.9% (24/1281) patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% of the 24 patients. Of the 17 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 13 reinitiated LIBTAYO after symptom improvement; of these, 5/13 (38%) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

Dr Schlesinger: So, turning back to Donna, let’s talk about the infusion process. What was that like for you?

Donna: I have my infusion treatment every 3 weeks. First, I have my bloodwork done, and once that’s approved, then I have a 30-minute infusion of LIBTAYO. And then I need to be monitored for about 30 minutes afterwards.

Dr Schlesinger: So Donna, what’s your medical team discussed with you regarding your treatment with LIBTAYO, and how has your experience with LIBTAYO been so far?

Donna: After starting treatment with LIBTAYO, my doctors saw an improvement in my locally advanced BCC. That was a sign to them that LIBTAYO was working for me. This is my experience, and others may have a different experience.

I experienced some side effects in the beginning like chapped lips. I had a mild rash, which did not require any treatment. The day after treatment, I’m exhausted and I sleep the whole day, but it gets better over the next few days. These are just my side effects. I understand everyone can be different. It is important that patients talk to their doctors about any side effects they’re having with LIBTAYO.

Dr Schlesinger: So, we’ll take a moment to go over the LIBTAYO Surround support programs. These can help eligible patients access LIBTAYO and navigate the insurance process. So, it can be broken into 3 main components. There's financial support for patients who may need that, and that includes the commercial copay program and the patient ambassador program for commercially insured patients. There's access to reimbursement support that can help you with benefit investigation, prior authorization process, also with product support as well. And then there's also additional Surround LIBTAYO support as well. So, there’s a QR code on the slide that you can scan and get more information about this. 

There's also robust educational resources that are available to patients receiving LIBTAYO, their caregivers, and healthcare professionals. So, the patient brochures are very helpful in the clinic where we can provide those to our patients when we are introducing LIBTAYO to them. They have a very nice starter kit, includes a blanket, things that you might need during infusion or afterwards. You can certainly get cold or tired, as you mentioned after an infusion. That's something as well. 

And then there's a formulary kit, which gives you additional information for us healthcare professionals in supporting our knowledge about LIBTAYO. So, you can speak to your representative, visit the website there to learn more about the available resources for you and your patients. 

Narrator: Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 1281 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.
• 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/dermatomyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica.
• Endocrine: Hypoparathyroidism
• Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Infusion-Related Reactions
Severe or life-threatening infusion-related reactions occurred in 0.2% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. Common symptoms of infusion-related reaction include nausea, pyrexia, and vomiting. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction.

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
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.

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 see full Prescribing Information. 

Dr Schlesinger: So Donna, when it comes to your treatment journey, what's been helpful for you?

Donna: My doctors and care team have been extremely supportive and informative throughout my entire treatment journey. Right from the start, my doctors have gone the extra mile to find treatment options, even when there was little known about locally advanced BCC. 

Also, I wouldn’t be where I am now without my support group. My family and friends give me the strength to carry on and are always there for me when I need them.

Dr Schlesinger: Have you had an opportunity to meet other people living with advanced BCC?

Donna: I have met people with advanced BCC; my friends and family have shared my contact information on social media forums and with people they may have met. This experience has been humbling and amazing all at the same time. Other patients often tell me that I inspire them, but they truly don’t realize how inspiring they are to me!

I have been living with this cancer for some time, and those who are newly diagnosed are really scared – I remember that feeling all too well. I have met people who have had cancer longer than me, and I have lost some people, while others are nearing their end… I feel blessed to have known them all. I will continue to be a warrior for them. I pray daily that no one has to live through this disease.

Also, I wouldn’t be where I am now without my support group. My kids give me the strength to carry on. My husband is my number one pillar. He makes me laugh and he always makes me feel like it’s all going to be okay. My sister is my biggest cheerleader, and my friends are always there for me when I need them.

Dr Schlesinger: So how has meeting other patients with advanced BCC impacted you?

Donna: Meeting these individuals has helped by making my light shine just a little bit brighter and my soul feel really full. They give me strength that I otherwise might not have had, but there are times it tears at my heart. Overall, it’s great to know that I’m not alone in this journey, and sharing my story gives me a purpose.

Dr Schlesinger: Donna, as we wrap up our discussion today, and this was an amazing discussion, is there anything else you would like to share with us?

Donna: I want to say that I don’t recall my clinical trial patient number, but let’s say I was patient number P346…that I was just a number on paper. I’m not. I’m Donna…I’m somebody’s wife, somebody’s mother, somebody’s sister, somebody’s friend.

So, try to remember on those days when it’s a little bit tough for you, you’re tired, that this is one of the faces that you’re working for. But the work that you’re doing is not only important to me but also to the people that I’m important to. Because my doctor knew about LIBTAYO, I was able to have an alternative treatment option, and I want to help others to be aware, too. It’s wonderful to be able to share my story with all of you, and I thank you for the opportunity.

Dr Schlesinger: Before we conclude, let’s do a quick recap of what we’ve discussed. So, on this, you’ll just notice that the indications for LIBTAYO are shown for you, the Warnings and Precautions went over. So LIBTAYO is the first and only treatment indicated for patients with locally advanced basal cell carcinoma or metastatic basal cell carcinoma who have been previously treated with a hedgehog pathway inhibitor or for whom hedgehog pathway inhibitor therapy is not appropriate. LIBTAYO offers over 8 years of clinical treatment experience. LIBTAYO is also the most prescribed immunotherapy by oncologists for patients across both advanced BCC and advanced cutaneous squamous cell carcinoma.

Thank you, Donna, for sharing your experience with us. Your perseverance and resilience are truly admirable, and I'm sure that our audience will agree. I wish you all the best and hope that you continue to inspire others with your story.

Indications and Usage

LIBTAYO is 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.

LIBTAYO is 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.

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.

Withhold or permanently discontinue LIBTAYO depending on severity of the adverse reaction (see Section 2 Dosage and Administration in the accompanying Full Prescribing Information). 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. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

The incidence and severity of immune-mediated adverse reactions were similar when LIBTAYO was administered as a single agent or in combination with chemotherapy.

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 2.6% (33/1281) of patients receiving LIBTAYO, including Grade 4 (0.3%), Grade 3 (0.6%), and Grade 2 (1.6%). Pneumonitis led to permanent discontinuation in 1.3% of patients and withholding of LIBTAYO in 1.4% of patients. Systemic corticosteroids were required in all patients with pneumonitis. Pneumonitis resolved in 61% of the 33 patients. Of the 18 patients in whom LIBTAYO was withheld, 10 reinitiated after symptom improvement; of these, 4/10 (40%) had recurrence of pneumonitis.

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% (25/1281) of patients receiving LIBTAYO, including Grade 3 (0.8%) and Grade 2 (0.9%). Colitis led to permanent discontinuation in 0.4% of patients and withholding of LIBTAYO in 1.2% of patients. Systemic corticosteroids were required in all patients with colitis. Colitis resolved in 56% of the 25 patients. Of the 16 patients in whom LIBTAYO was withheld, 6 reinitiated LIBTAYO after symptom improvement; of these, 4/6 (67%) had recurrence.

Immune-mediated hepatitis: LIBTAYO can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.4% (31/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 4 (0.3%), Grade 3 (1.6%), and Grade 2 (0.2%). Hepatitis led to permanent discontinuation of LIBTAYO in 1.4% of patients and withholding of LIBTAYO in 0.7% of patients. Systemic corticosteroids were required in all patients with hepatitis. Additional immunosuppression with mycophenolate was required in 13% (4/31) of these patients. Hepatitis resolved in 39% of the 31 patients. Of the 9 patients in whom LIBTAYO was withheld, 5 reinitiated LIBTAYO after symptom improvement; of these, 1/5 (20%) had recurrence.

Immune-mediated endocrinopathies:

• 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 0.5% (6/1281) of patients receiving LIBTAYO, including Grade 3 (0.5%). Adrenal insufficiency led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient. LIBTAYO was withheld in 1 (<0.1%) patient due to adrenal insufficiency and not reinitiated. Systemic corticosteroids were required in 83% (5/6) patients with adrenal insufficiency; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency had resolved in 17% of the 6 patients
• 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 0.5% (7/1281) of patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.3%) adverse reactions. Hypophysitis led to permanent discontinuation of LIBTAYO in 1 (<0.1%) patient and withholding of LIBTAYO in 2 (0.2%) patients. Systemic corticosteroids were required in 86% (6/7) of patients with hypophysitis. Hypophysitis resolved in 14% of the 7 patients. Of the 2 patients in whom LIBTAYO was withheld for hypophysitis, none of the patients reinitiated
• 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% (8/1281) of patients receiving LIBTAYO, including Grade 2 (0.3%) adverse reactions. No patient discontinued LIBTAYO due to thyroiditis. Thyroiditis led to withholding of LIBTAYO in 1 (<0.1%) patient. Systemic corticosteroids were not required in any patient with thyroiditis. Thyroiditis resolved in 13% of the 8 patients. Blood thyroid stimulating hormone increased and blood thyroid stimulating hormone decreased have also been reported
• Hyperthyroidism: Hyperthyroidism occurred in 3% (39/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (0.9%). No patient discontinued treatment and LIBTAYO was withheld in 7 (0.5%) patients due to hyperthyroidism. Systemic corticosteroids were required in 8% (3/39) of patients. Hyperthyroidism resolved in 56% of 39 patients. Of the 7 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% (87/1281) of patients receiving LIBTAYO, including Grade 3 (<0.1%) and Grade 2 (6%). Hypothyroidism led to permanent discontinuation of LIBTAYO in 3 (0.2%) patients. Hypothyroidism led to withholding of LIBTAYO in 9 (0.7%) patients. Systemic corticosteroids were required in 1.1% (1/87) of patients with hypothyroidism. Hypothyroidism resolved in 6% of the 87 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 and did not have recurrence of hypothyroidism
• 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% (1/1281) of patients (Grade 4). No patient discontinued treatment due to Type 1 diabetes mellitus. Type 1 diabetes mellitus led to withholding of LIBTAYO in 0.1% of patients, treatment was reinitiated after symptom improvement. Patient received long-term insulin therapy

Immune-mediated nephritis with renal dysfunction: LIBTAYO can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.7% (9/1281) of patients receiving LIBTAYO, including fatal (<0.1%), Grade 3 (<0.1%), and Grade 2 (0.5%). Nephritis led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 0.4% of patients. Systemic corticosteroids were required in all patients with nephritis. Nephritis resolved in 78% of the 9 patients. Of the 5 patients in whom LIBTAYO was withheld, 4 reinitiated LIBTAYO after symptom improvement; of these, 1/4 (25%) had recurrence.

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 1.9% (24/1281) of patients receiving LIBTAYO, including Grade 3 (0.9%) and Grade 2 (0.8%). Immune-mediated dermatologic adverse reactions led to permanent discontinuation in 0.2% of patients and withholding of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with immune-mediated dermatologic adverse reactions. Immune-mediated dermatologic adverse reactions resolved in 71% of the 24 patients. Of the 17 patients in whom LIBTAYO was withheld for dermatologic adverse reaction, 13 reinitiated LIBTAYO after symptom improvement; of these, 5/13 (38%) had recurrence of the dermatologic adverse reaction. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.

Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 1281 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
• 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/dermatomyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica
• Endocrine: Hypoparathyroidism
• Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection, other transplant (including corneal graft) rejection

Infusion-Related Reactions

Severe or life-threatening infusion-related reactions occurred in 0.2% of patients receiving LIBTAYO as a single agent. Monitor patients for signs and symptoms of infusion-related reactions. Common symptoms of infusion-related reaction include nausea, pyrexia, and vomiting. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction.

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

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

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 see full Prescribing Information.

US.LIB.24.09.0095 01/2025