Sponsored: Libtayo Draft
Seeing is believing: What the LIBTAYO study results mean to me
I’m a troubleshooter by profession. As a technology project manager, I’m used to analyzing problems and quickly coming up with solutions to keep my clients on-line. But when I first noticed a soft, squishy bulge under my left eye, I ignored it. I’d been dealing with cutaneous squamous cell carcinoma (CSCC) for eight years. I didn’t want to give cancer any more of my time and effort.
In the past, I had rounds of surgery to remove the cancer, followed by reconstructive surgery. I missed a lot of work and time with my wife. But CSCC doesn’t care about your work or your personal life.
Before long the bulge had grown to a point where I couldn’t ignore it. The skin on my left cheek area began to thicken and harden. It started to spread across my face toward my nose. When my cheek became numb, I had to concede that CSCC was back.
More than numbers
I knew I needed to do something to address my CSCC, but I was no longer a candidate for the kinds of treatments (surgery or radiation) that had helped me before. I was honestly very concerned. Thankfully, my ocular surgeon told me about LIBTAYO® (cemiplimab-rwlc) and referred me to an oncologist who used it in his practice. 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. He told me that LIBTAYO worked by blocking the programmed death receptor-1 pathway that cancer cells use as a defense against the body’s T cells, which target and kill abnormal cells. He explained that when the T cells are active again, they can help target, attack, and kill the cancer cells. He also showed me the results from the clinical trials.
After I left his office, I did my own research. Here’s what I learned: In a study of 137 patients with advanced CSCC (cancer that had spread or could not be cured by surgery or radiation), 63 out of 137 patients (46%) saw an improvement in their advanced CSCC with LIBTAYO.
Of these patients, 43 out of 137 (31%) saw tumors shrink (partial response) and 20 out of 137 patients (15%) saw tumors disappear completely (complete response).
In 50 out of 63 patients (79%) who responded to LIBTAYO, the response lasted 6 months or longer.
In 34 out of 63 patients (54%) who responded to LIBTAYO, the response lasted 12 months or longer.
In the same clinical trial, in a separate group of 56 patients with CSCC that had spread who took LIBTAYO at the recommended dose†:
23 out of 56 patients (41%) saw an improvement in their advanced CSCC
20 out of 56 patients (36%) saw tumors shrink (partial response)
3 out of 56 patients (5%) saw tumors disappear completely (complete response)
Of course, I also learned about the side effects. 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. After considering all the data and information, my oncologist and I decided that LIBTAYO was the right option for me.
LIBTAYO may not work for everyone.
*Patients were dosed by body weight.
LIBTAYO 350 mg over 30-minute infusion every 3 weeks.
After my second LIBTAYO infusion, I could see that the bulge under my eye was beginning to shrink. After six infusions, I could tell it was smaller still. When I had a totalbody PET scan, it confirmed my improvement.*
After I started LIBTAYO, I ended up experiencing hives and itching in different areas of my body. Throughout my treatment, I also noticed some fatigue for a few days after the infusions. Everyone’s experience is different, so be sure you talk to your doctor about whether LIBTAYO could be right for you. It may not work that way for everyone, of course.
In my line of work I have to be able to access any given situation and come up with the appropriate options based on the data I’m provided. That’s how I went about looking at LIBTAYO—an option for patients with CSCC that has spread or cannot be cured by surgery or radiation. After evaluating the data and potential risks, I decided LIBTAYO was an appropriate option for me.
*Individual results may vary.
Important Safety Information
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 (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 (abdomen), dark urine (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
- 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 (GVHD), in people who have received a bone marrow (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.
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:
- 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
— 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 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 and Sanofi at 1-877-542-8296.
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.
LIBTAYO is a prescription medicine used to treat people with a type of skin cancer called basal cell carcinoma that cannot be removed by surgery (locally advanced BCC) and have received treatment with a hedgehog pathway inhibitor (HHI) or cannot receive treatment with an HHI.
LIBTAYO is a prescription medicine used to treat people with a type of lung cancer called non–small cell lung cancer (NSCLC). LIBTAYO may be used as your first treatment when your lung cancer has not spread outside your chest (locally advanced lung cancer) and you cannot have surgery or chemotherapy with radiation, or your lung cancer has spread to other areas of your body (metastatic lung cancer), and your tumor tests positive for high “PD-L1,” and your tumor does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene.
It is not known if LIBTAYO is safe and effective in children.