2019-02-21T12:19:00
(BPT) – Montana native Bob Connors didn’t think much of a dry patch of skin on his face at first. But when it wouldn’t go away, it became the start of a decade-long battle with skin cancer. His journey, though arduous at times, is one of resilience, optimism and personal empowerment, and a reminder to never give up hope.
When he was 39 years old, Connors was living an active, healthy life. He had always considered himself a family man and was looking forward to spending time with his wife Barb and watching his kids grow up and start their own families.
The small patch of stubborn, dry skin on his face did not seem like it would alter these dreams — but when Connors decided to visit his dermatologist’s office out of “vanity,” he received a diagnosis that would change his life.
Connors learned he had cutaneous squamous cell carcinoma, commonly referred to as CSCC. When his doctor advised him to have it removed, he did it right away, thinking that would be the last of it — but it wasn’t. The cancer not only kept coming back, but began spreading down his jaw. Recognizing the seriousness of the situation, his dermatologist referred him to a hospital, where doctors discovered an underlying tumor. Suddenly, Bob was faced with major invasive surgery and, soon after, radiation and chemotherapy.
Over the course of the next decade Connors battled advanced CSCC and endured multiple surgeries as his tumors invaded deeper into his body. He lost over 50 pounds, and when one of the tumors reached his spine, he lost movement in his left arm and leg. Though Connors’ family and close friends did everything they could to help him fight the disease, the cancer always seemed to be one step ahead.
Yet Connors remained optimistic, even refusing to quit his job despite the toll the cancer was taking on his health. Maybe it was his upbringing in a small Montana town, but the idea that advanced CSCC could get the best of him was not something he was willing to accept — until his doctor solemnly told him they had exhausted all available treatment options, and there was nothing more they could do.
It seemed the cancer had won.
“I refused to give up hope, despite how devastating this news was for me and my family,” said Connors. “My son had just let me know he and his wife were expecting a baby.”
Connors and his wife decided it was time they explored other options. Through Connors’ extended family and healthcare team, he and his wife learned of a clinical trial that had just started for an investigational treatment called cemiplimab-rwlc, and Connors was eligible.
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. Finally, potential serious side effects can include problems in the lung, intestine, liver, hormone gland, kidney, skin, or in other organs.
After weighing the risks and benefits, Connors decided his best option was to enroll in the clinical trial. Although he experienced some side effects, after two months of treatment, Connors got the news he was praying for: his tumors were shrinking.
“It was an incredible day for me and my family, especially since we knew that not everyone would experience the same results. The doctor was clear there were no guarantees.”
Connors recently welcomed his first grandchild into the world. He also continues to serve as the superintendent of his local school system, where he often shares his experience with students and teaches them the importance of being a proactive and educated patient.
“If you’re going through this, just keep looking forward,” says Connors. “Keep your eyes on the windshield, not the rearview mirror.
Cemiplimab-rwlc, also known as LIBTAYO, is now 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, and visit www.LIBTAYO.com.
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.
If you or someone you know has been diagnosed with advanced CSCC, visit LIBTAYO.com to learn more, and talk to a doctor.
