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Serving as a caregiver to someone with cancer doesn’t just mean making meals, accompanying them to appointments, and lending emotional support—though these are all large parts of the job description. It also means being able to understand and interpret medical information from your loved one’s doctor, along with knowing the ins and outs of their treatment plan—from picking the right one to help managing side effects.
And when someone you love has non–small cell lung cancer (NSCLC), which accounts for 85% of all lung cancers, it also means knowing about innovative advances in immunotherapy—therapies worth exploring that are extending lives where treatment options were once limited.
To make the process a little easier, we’ve provided a list of questions and topics for your loved one’s next doctor’s visit, as well as the best treatment options for them. You may want to print them out before your next visit.
1. What type of NSCLC are we dealing with?
Not all NSCLC is created equal. There are 3 different types of NSCLC. With adenocarcinoma, the cancer begins in cells of glands that secrete mucus and other substances and are often found in an outer area of the lungs. Squamous cell carcinoma starts in the flat cells that line the passages of your respiratory tract and are found in the center of your lungs. Finally, large cell carcinoma is cancer that can occur in any part of the lungs. This type tends to be more aggressive than the other 2 types of NSCLC.
2. What tests will we need to decide on treatment?
Once your doctor diagnoses your loved one with advanced NSCLC, the next step is staging. Of the 5 possible stages of cancer, the advanced stages are classified as stage 3 or 4. Stage 3 means the cancer has spread to lymph nodes farther away from where it started within the chest. It can also mean it hasn’t spread to other parts of the body, but the cancer is bigger than stage 2 cancer. You may also hear stage 3 referred to as locally advanced NSCLC. With stage 4 NSCLC, the cancer has spread to other organs such as the brain, liver, or the other lung (also known as metastatic NSCLC). Knowing the stage gives the doctor a better understanding of how to treat your cancer—with surgery, chemotherapy, radiation, or an immunotherapy drug such as LIBTAYO® (cemiplimab-rwlc).
In addition to staging, your physician may suggest biomarker testing. This involves testing the tumor tissue for mutations in the DNA, as well as levels of a certain protein called PD-L1. The findings will determine if certain treatments such as LIBTAYO are the right fit.
3. Based on those test results, treatment is promising.
LIBTAYO is not for those who have the EGFR, ALK, and ROS1 mutations. LIBTAYO is appropriate for tumors with the BRAF and NTRK mutations, and for tumors with levels greater than or equal to 50% of PD-L1, a protein that binds to immune cells and prevents them from killing other cells, including cancer cells. LIBTAYO, an immunotherapy drug, blocks PD-1 and prevents the cancer cell protein from binding to T-cell receptors. To be a candidate for LIBTAYO, PD-L1 levels should be greater than or equal to 50%.
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.
Please see additional Important Safety Information below.
4. What should we know about immunotherapy?
Until recently, treatment options for advanced NSCLC were very limited. Immunotherapy is giving these patients a new option that’s extending lives and hope when advanced NSCLC is not treatable through surgery, chemotherapy, or radiation. Immunotherapy, administered by an oncologist, works with the body’s own immune cells, called T cells, to kill cancer cells. Immunotherapy 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. LIBTAYO is a type of immunotherapy drug known as a checkpoint inhibitor. Checkpoint inhibitors are a type of immunotherapy used in the treatment of advanced NSCLC. A checkpoint is similar to a brake on an immune cell that stops it from killing other cells, including cancer cells. By removing the brake, the immune cell can attack cancer. LIBTAYO is a treatment that works by blocking PD-1 to inhibit binding with the cancer cell protein so it can stay active, killing the cancer cells.
LIBTAYO was studied in a clinical trial that compared patients with advanced NSCLC who received LIBTAYO at 350 mg every 3 weeks with those who received chemotherapy containing platinum. In this study, half the patients taking LIBTAYO (178 out of 356 patients) were alive at 22.1 months versus half the patients taking chemotherapy (177 out of 354 patients), who were alive at 14.3 months.
LIBTAYO reduced the risk of cancer spreading, growing or getting worse by 41% compared with chemotherapy.
|Median progression-free survival (PFS)*|
– Half of the patients on LIBTAYO were alive without their cancer spreading, growing, or getting worse at 6.2 months, compared with 5.6 months for patients on chemotherapy
*Median progression free survival (PFS) is the time in a trial—expressed in months or years—when half of the patients are still living without their cancer spreading, growing, or getting worse.
– As of March 2020, advanced NSCLC had not progressed in 155 out of 356 patients (43%) taking LIBTAYO compared with 92 out of 354 patients (26%) taking chemotherapy†
†Patients were enrolled between June 27, 2017, and February 27, 2020. Patients were treated with LIBTAYO for an average of 27 weeks. The study is still ongoing, and patients will be followed up for up to 4 years.
LIBTAYO may not work for everyone.
The most common side effects reported in the 355 patients with advanced NSCLC taking LIBTAYO were muscle or bone pain, rash, anemia (low red blood cell count), tiredness, loss of appetite, and pneumonia, but the drug can cause additional side effects. Call your physician for medical advice about potential side effects. You can report your loved one’s side effects to the FDA at 800-FDA-1088, as well as Regeneron Pharmaceuticals and Sanofi at 877-542-8296.
If you or someone you love has advanced NSCLC and would benefit from learning more about LIBTAYO, talk to your doctor and visit LIBTAYO.com for additional resources and to download the LIBTAYO patient brochure.
Important Safety Information (continued)
Call or see your health care 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 health care 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 health care 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 health care 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:
- 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 and Sanofi at 1-877-542-8296.
Please click here for full Prescribing Information, including Medication Guide.
What is LIBTAYO?
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.