Frequently asked questions

After an NSCLC diagnosis, one of the first steps doctors will take is to try to determine the size of the cancer in the body and where it is located. This is called staging. The stage of NSCLC mainly describes the size of the tumor and if it has spread to other areas of the body. The lower the stage number, the less advanced the cancer is.

There are different staging systems for different cancers, but the most common is the numbered cancer staging system that identifies 5 possible cancer stages:

Stage 0: Cancer cells are located in the lining of the airways and have not spread.

Stage 1: The cancer is still small and has not spread outside the lungs or to the lymph nodes.*

Stage 2: The cancer may be larger than in stage 1 or may have spread to the lymph nodes* near where the cancer started.

Stage 3: The cancer may have spread to the lymph nodes* farther away from where it started within the chest. The cancer has not spread to other parts of the body and may be larger than those in stage 2. It is sometimes referred to as locally advanced NSCLC.

Stage 4: The most advanced form of cancer. In stage 4 cancer, the disease is called metastatic NSCLC, which means that the cancer has spread to other organs such as the other lung, brain, liver, or to other parts of the body.

*Lymph nodes are like filters that remove germs. They contain immune cells that can help fight infection.

When NSCLC is diagnosed as stage 3, it means that the cancer may have spread to the lymph nodes* farther away from where it started within the chest. The cancer has not spread to other parts of the body and may be larger than those in stage 2. It is sometimes referred to as locally advanced NSCLC. Stage 4 is the most advanced form of cancer. In stage 4 cancer, the disease is called metastatic NSCLC, which means that the cancer has spread to other organs such as the other lung, brain, liver, or to other parts of the body.

*Lymph nodes are like filters that remove germs. They contain immune cells that can help fight infection.

Biomarker testing is an important part of understanding your unique advanced NSCLC diagnosis. It is used in the advanced stages of NSCLC and involves testing tumor tissue for mutations or abnormalities in the DNA and levels of specific proteins in, or on the surface of, the tumor. Biomarker testing is usually done during a biopsy because it requires a sample of the tumor tissue. Biomarkers tell your doctor that a mutation or an abnormality may be present and may lead to a better understanding of which treatment to use and how you may respond to treatment.

There are many different biomarker tests that may help you and your doctor decide the most appropriate treatment options to help treat your advanced NSCLC. Your doctor may test you for more than one biomarker. Below are some of the most common types of biomarkers.

• Epidermal growth factor receptor (EGFR)
• Anaplastic lymphoma kinase (ALK)
• ROS proto-oncogene 1, receptor tyrosine kinase (ROS1)
• Programmed death ligand 1 (PD-L1)

ALK, EGFR, and ROS1 are some of the biomarkers found in advanced NSCLC. Your doctor may test you for more than one of these biomarkers to help decide the most appropriate treatment options to help treat your advanced NSCLC. Treatment options may be appropriate for you based on the absence or presence of certain biomarkers.

Anaplastic lymphoma kinase (A-nuh-PLAS-tik lim-FOH-muh KY-nays) (ALK)

The ALK gene causes cells to grow and divide more rapidly. ALK mutations may cause tumors to grow out of control. LIBTAYO is not an appropriate therapy for patients who test positive for ALK mutations.

Epidermal factor growth receptor (eh-pih-DER-mul grothe FAK-ter reh-SEP-ter) (EGFR)

The EGFR protein is involved in cell growth and cell survival. EGFR mutations may cause cancer cells to grow and spread in the body more rapidly. LIBTAYO is not an appropriate therapy for patients who test positive for EGFR mutations.

ROS proto-oncogene 1, receptor tyrosine kinase (ros prow-tuh-aang-kow-jeen wuhn, reh-SEP-ter TY-ruh-seen KY-nays) (ROS1)

The ROS1 protein is involved in sending signals in cells and in cell growth. ROS1 mutations may cause cancer cells to grow. LIBTAYO is not an appropriate therapy for patients who test positive for ROS1 mutations.

Yes, you will need a biomarker test before starting LIBTAYO.

• If you tested negative for abnormal EGFR, ALK, and ROS1 biomarkers, LIBTAYO in combination with chemotherapy may be an appropriate treatment option for your advanced NSCLC regardless of your PD-L1 levels
• If your cancer tested positive for high PD-L1 and if you tested negative for abnormal EGFR, ALK, and ROS1 biomarkers, LIBTAYO used alone may be an appropriate treatment option for your advanced cancer

LIBTAYO is not chemotherapy or radiation therapy. LIBTAYO is a type of immunotherapy treatment called a programmed death receptor-1 (PD-1) inhibitor.

Yes, LIBTAYO can be used in combination with chemotherapy that contains a platinum medicine to treat people with a type of lung cancer called non–small cell lung cancer (NSCLC).

It may be used in adults as your first treatment option 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 does not have an abnormal “EGFR,” “ALK,” or “ROS1” gene

Immunotherapy is a form of systemic drug therapy (a type of drug that moves through the 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 and keep growing. Immunotherapy helps the immune system recognize, attack, and kill the cancer cells. Immunotherapy is given by an oncologist and often used during the advanced stages (stages 3 and 4). It is not chemotherapy. Some immunotherapies can be given alone or in combination with chemotherapy in certain patients.

Immunotherapy can also cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work.

LIBTAYO is a medicine that may treat certain types of 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.

LIBTAYO can cause serious side effects, including:

• See “What is the most important information I should know about LIBTAYO?”

The most common side effects of LIBTAYO when used alone include tiredness, muscle or bone pain, rash, diarrhea, and low levels of red blood cells (anemia).

The most common side effects of LIBTAYO when used in combination with platinum-containing chemotherapy include hair loss; muscle or bone pain; nausea; tiredness; numbness, pain, tingling, or burning in your hands or feet; and decreased appetite.

These are not all the possible side effects of LIBTAYO or LIBTAYO in combination with chemotherapy.

Make sure to read all of the important information about LIBTAYO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 received radiation treatment to your chest area
• 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 with LIBTAYO
• You should use an effective method of birth control during your treatment and for at least 4 months after the last dose of LIBTAYO. Talk to 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.

• Your healthcare provider will give you LIBTAYO into your vein through an intravenous (IV) line over 30 minutes
• LIBTAYO is usually given every 3 weeks
• This is the infusion schedule for LIBTAYO whether it is used alone or in combination with chemotherapy
• Your healthcare provider will decide if LIBTAYO used alone or in combination with chemotherapy is an appropriate treatment for you
• Your healthcare provider will decide how many treatments you will need
• Your healthcare provider will do blood tests to check you for side effects
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment

Every person is different and not everyone will respond to LIBTAYO the same way. LIBTAYO may not work for some people with advanced NSCLC. If you have any questions about treatment with LIBTAYO, talk to your doctor.

LIBTAYO Surround offers patient support that may help with access to medication, including financial support when eligible patients need assistance with out-of-pocket costs.

LIBTAYO is covered by most major insurers, and LIBTAYO Surround may help you access LIBTAYO and navigate the health insurance process.