Immunotherapy helps man battle advanced skin cancer when surgery was no longer an option

(BPT) - Often it’s impossible to know the cause of a cancer. That wasn’t the case for Dale Biggs. When he thinks back to the origins of his cutaneous squamous cell carcinoma (CSCC), Biggs knows his battle with one of the most common types of skin cancer was a direct product of the years he spent working outdoors. According to the American Cancer Society, CSCC typically appears on areas of the body exposed to the sun such as the face, neck and backs of the hands, and is more commonly diagnosed than melanoma.

In the years he spent in the sun for his job, Biggs routinely got sunburned, even through the hair on his scalp. At the time, the burns were a minor irritation. But their lasting effects would come to play a dramatic role in his future.

Biggs’ battle with CSCC began in 1985, when the first scaly dry patches started to appear on his skin. He was diagnosed with actinic keratosis, a pre-cancerous condition that can lead to CSCC, but this didn’t bother him. Both his brother and sister had received a similar diagnosis, and based on their experiences, it hadn’t become invasive.

By 2008 his skin lesions had started to look more dangerous, and, after being diagnosed with CSCC, he underwent several Mohs surgery procedures to remove them, but they kept coming back. His father-in-law had undergone similar procedures before — including one that removed significant skin from his forehead and his nose. Because of this, Biggs began to worry that the procedures and the disease itself might leave him visibly scarred. But he continued to fight.

More large bumps were removed in 2015, and it was then that Biggs realized he couldn't continue his treatment regimen as it was. He needed more answers; he needed to know why the bumps on his scalp and around his body continued to appear.

He revisited his dermatologist, who took a biopsy that revealed what Biggs had feared — his CSCC was becoming advanced. By the time he was able to see a surgical oncologist a month later, new tumors had spread across the top of his head. Upon seeing the state of his condition, the surgical oncologist told him, “I’ll have to scalp you.”

The following procedure removed a large portion of Biggs’ scalp all the way down to the bone. Biggs continued to follow his doctor’s recommendations, but the tumors were still coming back. He was told additional surgery and radiation would no longer be a curative option for his advanced CSCC. He was losing hope, until he learned of a clinical trial for an investigational treatment called cemiplimab-rwlc.

Cemiplimab-rwlc is an immunotherapy that may help restore the body’s immune system activity against cancer cells. However, the drug is not without risks. Cemiplimab-rwlc can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. Furthermore, these problems may happen anytime during treatment or even after treatment has ended. Potential serious side effects can include problems in the lung, intestine, liver, hormone gland, kidney, skin, or in other organs.

With a major decision in front of him, Biggs considered the risks and potential benefits before agreeing to enroll in the clinical trial. After two months of treatment, Biggs began to see noticeable changes in his skin tumors. The tumors were shrinking. By the third month, they were no longer visible.

These days, Biggs has become an advocate for others facing a cancer diagnosis and has shared his story at several patient conferences. He knows that not everyone will experience the same results that he did, but he encourages others — no matter their condition — to never give up. Learn more about how CSCC can become invasive and a treatment option available for advanced stages of the disease.

Cemiplimab-rwlc, also known as LIBTAYO, is approved by the U.S. Food & Drug Administration (FDA) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for curative surgery or curative radiation. LIBTAYO is the first and only approved treatment for patients with advanced CSCC.

In the LIBTAYO advanced CSCC clinical trials, 47.2 percent of patients saw their tumors respond to treatment, with 3.7 percent seeing their tumors disappear completely (complete response) and 43.5 percent seeing their tumors shrink to some degree but not completely (partial response).

The most common side effects seen in clinical trials occurring in more than 10 percent of patients were fatigue, rash, diarrhea, nausea, musculoskeletal pain, pruritis, constipation, and decreased appetite.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

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

LIBTAYO is a medicine that may treat a type of skin cancer 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. 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 symptoms of the following problems or these symptoms get worse:

  • Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
  • Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
  • Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
  • Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
  • Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
  • Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
  • Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
  • Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
  • Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.

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 delay or completely stop treatment if you have severe side effects.

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 had an organ transplant;
  • have lung or breathing problems;
  • have liver or kidney problems;
  • have diabetes;
  • 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 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 and Sanofi at 1-877-542-8296.

Please see accompanying full Prescribing Information, including Medication Guide.

What is LIBTAYO?

LIBTAYO 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.

It is not known if LIBTAYO is safe and effective in children.

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