What is LIBTAYO?

Intro music

VO:

LIBTAYO® (cemiplimab-rwlc) is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

LIBTAYO is a medicine that may treat certain cancers by working with your immune system.
LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Please see Important Safety Information throughout this video and accompanying full Prescribing Information including Medication Guide available via the adjacent link and at www.LIBTAYO.com.

HOST: Hello and welcome to LIBTAYO (cemiplimab-rwlc) Real Conversations About Advanced CSCC sponsored by Regeneron. I’d like to introduce our featured guest, John Strasswimmer, MD, PhD, fellow of the American College of Mohs Surgery and certified by the American Board of Dermatology.

Dr. Strasswimmer received his M.D. and Ph.D. in Cancer Molecular Biology from Tufts University. He went on to teach at Harvard Medical School, served as Staff Dermatologist at Massachusetts General Hospital, and is currently in private practice in Delray Beach, Florida. He has performed more than 10,000 facial skin cancer surgeries with cosmetic reconstruction. Dr. Strasswimmer, thank you for joining us!

DR. STRASSWIMMER: Thank you, Elizabeth. It’s a pleasure to be here to talk about this important topic.

HOST: Well, let’s dive right in! Exactly what is CSCC and how does it start?

DR. STRASSWIMMER:
As this slide shows, cutaneous squamous cell carcinoma is a type of skin cancer that starts in squamous cells, which are a type of flat, thin cell in the top layer of the skin. CSCC occurs when the cells in the top layer of the skin, also called the epidermis, mutate in their DNA. The mutations tell those skin cells to grow out of control, to continue living and dividing when normal cells would die. Most of the DNA mutations in these skin cells are caused by ultraviolet exposure from sunlight, tanning lamps, and tanning beds. Most cases of CSCC are easily treated and curable when detected early. But some become advanced, which means that the CSCC has spread or cannot be cured by radiation or by surgery.

HOST: So, Dr. Strasswimmer, how prevalent is cutaneous squamous cell carcinoma?

DR. STRASSWIMMER: Cutaneous squamous cell carcinoma or CSCC is the second most common type of skin cancer in the United States, with about 700,000 people in the U.S. diagnosed each year. This graphic shows that about 5% of patients diagnosed with CSCC will progress to advanced disease.

HOST: So, CSCC is more prevalent than most people know (according to the 2019 Harris Poll survey). Why don’t we hear more about it?

DR. STRASSWIMMER: In dermatology, Elizabeth, we have focused much of our education on melanoma. Perhaps, because we have effective treatments for early squamous cell carcinoma, we have been remiss in not sharing the importance of advanced CSCC and the risk of progressive disease. It’s time to move forward with that.

HOST: Well, how long have you treated patients with CSCC?

DR. STRASSWIMMER: I have treated patients with cutaneous squamous cell carcinoma for 15 years, including many with advanced squamous cell carcinoma both locally advanced as well as metastatic.

HOST: We hear so much about skin cancer in general, but many people haven’t heard of CSCC. What are the initial signs or symptoms?

DR. STRASSWIMMER: As this graphic shows, CSCC can have different appearances and can vary from person to person. It grows as a lesion on the surface of the skin, but it may also spread to other parts of the body and can even spread inside the body. When the CSCC has spread extensively or aggressively, or in some cases has not responded to multiple treatments and has returned repeatedly, it is considered advanced because it has spread or cannot be cured by surgery or radiation.

DR. STRASSWIMMER: There are two forms of advanced CSCC: locally advanced CSCC and metastatic CSCC. This picture shows when a locally advanced tumor has become large or have grown deep into underlying tissues, muscles, or nerves, destroying nearby healthy tissue. And metastatic is when tumors spread beyond their original location of the body to other parts or organs of the body.

HOST: Well, tell us about how you diagnose patients with CSCC? What tests are run?

DR. STRASSWIMMER: There are 3 parts to the diagnosis of CSCC. As we see here, initially, we perform an in-office examination, along with a skin biopsy to confirm the diagnosis of cutaneous squamous cell carcinoma. This biopsy may also reveal if the cancer has some particular features that make it more aggressive, such as being moderately or poorly differentiated, meaning that it has a more aggressive type than the common well- differentiated cutaneous squamous cell carcinoma.
Then, if we suspect advanced CSCC may be present, it is very important to have an initial imaging test, such as a CT or PET scan. This will help diagnose the extent of the disease. We would of course, also perform a full workup of blood chemistry and a complete blood count.

HOST: This slide shares the specialized doctors who maybe involved in your care and can help determine the right treatment options for you.

• Medical oncologists: Doctors who diagnose and treat cancers
• Surgical oncologists: Doctors with specialized training to manage and remove tumors and other cancerous tissue through surgery
• Radiation oncologists: Doctors who specialize in radiation therapy, a treatment that uses high doses of radiation to kill cancer cells and shrink tumors
• Dermatologists: Doctors who evaluate and treat disorders of the skin
• Mohs surgeons: Doctors who use a specific surgical technique, called Mohs surgery, to treat skin cancer. They progressively remove and examine thin layers of cancerous skin until no cancer cells remain.

If possible, it is important that your doctor considers working with a team of multidisciplinary healthcare providers when helping you look at all of your treatment options, and that they work together to develop a treatment plan specific to you.

HOST: Dr. Strasswimmer, how do you work with your patients’ oncologists?

DR. STRASSWIMMER: We work regularly by direct communication at every step. That includes following a patient’s bloodwork, clinical improvement, and imaging studies. Dermatologists have a central role in advocating for the treatment of their patients, and they collaborate with the oncologists in setting treatment goals.

HOST: How is CSCC treated?

DR. STRASSWIMMER: There are several treatment options that may be used to treat CSCC. Your doctor will help you choose the best treatment for you based on how advanced your cancer is and your overall health.

As this slide illustrates, most CSCC cases can be cured with surgery or radiation when found and treated early. In advanced stages these can become more difficult to treat successfully.

During surgery, the intent is to remove the cancerous tumor and affected surrounding tissue. Some people with advanced CSCC may have multiple surgeries as part of their treatment to remove tumors on the head, neck, and other parts of the body. Depending on the extent and location of the surgery, some may need reconstructive surgery to repair areas of the skin or other structures of the body such as the nose or ear affected by the tumor.

Surgery for CSCC is typically performed by a Mohs surgeon, surgical oncologist, or another trained surgical specialist, such as a head and neck surgeon.

Advanced CSCC may also be treated with radiation therapy, which is a type of cancer treatment that uses beams of intense energy, most often X- rays, to kill cancer cells and shrink tumors. Radiation therapy is given by a radiation oncologist.

Radiation therapy can also be used after surgery to kill any potential remaining cancer cells.This may lower the risk of cancer coming back after surgery.

If CSCC is more advanced or cannot be cured by surgery or radiation, other treatments might be used other than surgery or radiation.

DR. STRASSWIMMER: Your body’s own immune system is very important in fighting cancer, and sometimes it needs help. As we see here, immunotherapy may also be used to treat metastatic CSCC or locally advanced CSCC when it cannot be cured by surgery or radiation. Immunotherapy is a form of systemic drug therapy (a type of drug that moves through your body) that may help your immune system fight cancer. Your body might not attack cancer because the cancer cells have developed ways to avoid the immune system. Immunotherapy helps the immune system recognize, attack, and kill the cancer cells. Immunotherapy is given by an oncologist. It is not chemotherapy, which is another type of systemic drug therapy.

Immunotherapy can cause your immune system to attack normal organs and tissues in your body, which may cause serious side effects.

HOST: LIBTAYO (cemiplimab-rwlc) is a type of immunotherapy. Dr. Strasswimmer, how long have you been recommending LIBTAYO to treat advanced CSCC that has spread or cannot be cured by surgery or radiation?

DR. STRASSWIMMER: I have been recommending LIBTAYO since its FDA approval in 2018. My practice has been focused on skin cancer.

I kept an eye on the data regarding cemiplimab-rwlc as it went through clinical trials. When LIBTAYO was approved by the FDA to treat CSCC that has spread or cannot be cured by surgery or radiation, I began to include it as a possible treatment option for my appropriate patients.

HOST: Dr. Strasswimmer, how is LIBTAYO believed to work with your immune system to help treat advanced CSCC?

DR. STRASSWIMMER: LIBTAYO was the first medicine approved by the Food and Drug Administration (FDA) to treat CSCC that has spread or cannot be cured by surgery or radiation. LIBTAYO is a type of immunotherapy called a programmed death receptor-1 (PD-1) inhibitor. LIBTAYO is not chemotherapy or radiation.

Sometimes, cancers make a molecule called programmed death receptor-1 ligand, which renders our body’s cancer- fighting immune cells, the T cells, inactive. The T cells are an important part of our immune system that helps our body fight cancer.

LIBTAYO is a treatment that works by blocking PD-1 receptors to inhibit binding with the cancer cell protein. The T cell then remains active, so it can attack and kill the cancer cell.

We know that advanced cutaneous squamous cell carcinoma is a fast-moving cancer; therefore, it’s important for patients and caregivers to understand treatment options, and what to expect based on clinical data and your healthcare team’s personal experience with treating their patients.

VO: The following is LIBTAYO Important Safety Information: Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: lung, intestinal, liver, hormone gland, kidney, or skin problems as well as problems in other organs and tissues.

These are not all of the immune system problems that can happen with LIBTAYO. Additionally, severe infusion reactions may occur as well as complications in patients who have received a transplant. The most common side effects of LIBTAYO include muscle or bone pain, tiredness, rash, and diarrhea.

HOST: The efficacy of LIBTAYO was studied in a clinical trial of 137 patients with CSCC that had spread or could not be cured by surgery or radiation—and who were then treated with LIBTAYO dosed by their body weight.

HOST: In that clinical trial of 137 patients with CSCC that had spread or could not be cured by surgery or radiation—and who were then treated with LIBTAYO, dosed based on their body weight:

• 63 out of 137 patients (or 46%) saw an improvement in their condition with LIBTAYO
• 43 out of 137 patients (or 31%) had a partial response– they saw tumors shrink
• 20 out of 137 patients (or 15%) had a complete response– they saw tumors disappear completely
• Responses lasted 6 months or longer in 50 out of 63 patients (or 79%) who responded to LIBTAYO and 12 months or longer in 34 out of 63 patients (or 54%)

HOST: In the same clinical trial, in a separate group of 56 patients with CSCC that had spread or could not be cured by surgery or radiation treated with LIBTAYO at the recommended dose:

• 41% of patients (or 23 out of 56) saw an improvement in their advanced CSCC with LIBTAYO
• 20 out of 56 of those patients (or 36%) had a partial response
• 3 out of 56 of those patients (or 5%) had a complete response
• In 15 out of 23 patients (or 65%) who responded to LIBTAYO, the response lasted 6 months or longer

HOST: In a different clinical trial of 26 patients with CSCC that had spread or could not be cured by surgery or radiation—and who were then treated with LIBTAYO dosed by body weight:

• 50% of patients (13 out of 26) saw tumors shrink (all partial responses)
• In 11 out of 13 patients (or 85%) who responded to LIBTAYO, the response lasted 6 months or longer

In these trials, responses lasted between 1 month and more than 2 years (or 24.2+ months); the plus sign (+) denotes ongoing at last assessment.

It is important to note that LIBTAYO may not work for everyone.

HOST: In two LIBTAYO clinical trials of 219 patients with advanced CSCC, the most common side effects reported were tiredness, rash, diarrhea, muscle or bone pain, nausea, itching, cough, constipation, joint pain, anemia (low red blood cell count), vomiting, hypothyroidism (underactive thyroid), and loss of appetite.

• These are not all the possible side effects of LIBTAYO
• Call your doctor for medical advice about side effects

HOST:

• LIBTAYO is an IV infusion (350 mg) given over 30 minutes
• Treatment with LIBTAYO happens once every 3 weeks
• Infusion reactions may happen while you are receiving the drug. Infusion reactions can sometimes be severe. Signs of these problems may include nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, and facial swelling. Tell your doctor right away if you start to experience any of these symptoms
• Your healthcare provider will decide how many treatments you will need
• Your healthcare provider will do blood tests to check you for side effects

HOST: The following is LIBTAYO Important Safety Information and list of side effects. You should always talk to your doctor if you experience these or any other side effects while taking LIBTAYO.

What is the most important information I should know about LIBTAYO?

LIBTAYO is a medicine that may treat certain cancers by working with your immune system. LIBTAYO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life- threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

• Lung problems: cough, shortness of breath, or chest pain
• Intestinal problems: diarrhea (or loose stools) or more frequent bowel movements than usual, stools that are black, tarry, sticky or have blood or mucus, or severe stomach-area (abdomen) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (or abdomen), dark urine (or tea colored), or bleeding or bruising more easily than normal
• Hormone gland problems: headache that will not go away or unusual headaches, eye sensitivity to light, eye problems, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, urinating more often than usual, hair loss, feeling cold, constipation, your voice gets deeper, dizziness or fainting, or changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, or loss of appetite

HOST:

• Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers in mouth or nose, throat, or genital area, fever or flu-like symptoms, or swollen lymph nodes
• Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with LIBTAYO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles, confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs, double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight, persistent or severe muscle pain or weakness, muscle cramps, low red blood cells, or bruising
• Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: nausea, chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain, or facial swelling
• Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had
• Complications, including graft-versus- host disease (or GVHD), in people who have received a bone marrow (or stem cell) transplant that uses donor stem cells (allogeneic) These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with LIBTAYO. Your healthcare provider will monitor you for these complications

Getting medical treatment right away may help keep these problems from becoming more serious.Your healthcare provider will check you for these problems during your treatment with LIBTAYO. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with LIBTAYO if you have severe side effects.

HOST: Before you receive LIBTAYO, tell your healthcare provider about all your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. LIBTAYO can harm your unborn baby Females who are able to become pregnant:
  • Your healthcare provider will give you a pregnancy test before you start treatment
  • You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of LIBTAYO. Talk with your healthcare provider about birth control methods that you can use during this time
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LIBTAYO
• are breastfeeding or plan to breastfeed. It is not known if LIBTAYO passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of LIBTAYO include muscle or bone pain, tiredness, rash, and diarrhea. These are not all the possible side effects of LIBTAYO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals at 1-877-542-8296.

Please see full Prescribing Information including Medication Guide available via the adjacent link and at www.LIBTAYO.com

HOST: LIBTAYO also offers patient support to eligible patients through a program called LIBTAYO Surround. Your doctor is your trusted source for information about your condition and treatment. LIBTAYO Surround may be able to provide you with resources and support to assist you.

HOST: LIBTAYO Surround helps eligible patients access LIBTAYO and navigate the health insurance process.

This may include assistance with out-of- pocket costs, including a commercial co-pay program, patient assistance program, and help finding other ways to afford your medicine.

VO: To enroll in LIBTAYO Surround®, you can:

• Talk to your doctor about your interest in enrolling
• Call LIBTAYO Surround at 1.877.LIBTAYO (that’s 1.877.542.8296) and select Option 1. You can call any time between 8:00 AM and 8:00 PM Eastern Time, Monday through Friday Or you can…
• Visit LIBTAYO.com to enroll online

If you speak a language other than English, LIBTAYO Surround provides assistance in 240 languages so you can better understand the support we can offer you.

HOST: Dr. Strasswimmer, what do you want patients to know about advanced CSCC?

DR. STRASSWIMMER: It’s important, Elizabeth, for patients to understand how serious advanced CSCC can be. It’s essential for anybody with a new growth to have it examined by a board-certified dermatologist, particularly if it is associated with any pain, discomfort, or bleeding. That way, they can work with their dermatologist to determine a treatment plan that’s right for them.

HOST: Thank you, Dr. Strasswimmer!

DR. STRASSWIMMER: Thank you, Elizabeth, for helping me shed additional light on this important discussion.

HOST: And we both appreciate everyone who tuned in for LIBTAYO Real Conversations about Advanced CSCC. Thank you for watching! For more information about advanced CSCC or LIBTAYO, go to LIBTAYO.com.