Libtayo (cemiplimab-rwlc) is a medicine that is used for certain types of cancer, including skin cancers and non-small-cell lung cancer (NSCLC). This article will focus on using Libtayo for NSCLC. Libtayo may be used by itself or along with other medicines to treat NSCLC.
How Does Libtayo Work for Non-Small-Cell Lung Cancer (NSCLC)?
Libtayo is a specific kind of medicine called immunotherapy. Immunotherapies work by helping your body’s own immune system work to fight against cancer. Libtayo works by attaching itself to a receptor called programmed cell death protein 1 (PD-1) on specific immune system cells called T cells. PD-1 can show up on these cells when cancer has activated or exhausted the T cells. It blocks PD-1 on cancer cells and stops them from sending signals that make your immune system weaker. This allows normal T cells in your immune system to find cancer cells and kill them to slow or stop tumors from growing.
What Type of NSCLC Is Libtayo Used For?
NSCLC may be treated with Libtayo if it is advanced or has spread to other parts of the body (metastatic). Libtayo may be used by itself or along with another medicine to treat NSCLC.
It may be used by itself as an initial (first-line) treatment for advanced or metastatic NSCLC that has a programmed death ligand (PD-L1) expression of at least 50%. PD-L1 expression is a measurement of how many of the cancer cells have the PD-1 receptor that Libtayo is able to target. The NSCLC must not have EGFR, ALK, or ROS1 mutations, which are mutations that other medicines can target.
Libtayo may also be used along with a platinum-based chemotherapy as an initial (first-line) treatment for advanced or metastatic NSCLC that does not have other targetable mutations of EGFR, ALK, or ROS1. It does not matter what the PD-L1 expression is for this use.
How Do I Use Libtayo for NSCLC?
Doses of Libtayo are given by an intravenous (IV) infusion through a blood vessel in your arm over a period of time. Your dose will be given by a health care provider every three weeks in a hospital, clinic, or infusion center. If your cancer responds to the medicine, you will receive Libtayo infusions for up to 24 months (two years). If your cancer grows or spreads, or you have certain side effects, you may stop using Libtayo earlier than 24 months. If you have certain side effects to the medicine, your health care provider may pause your infusions or stop them altogether.
If you miss an appointment for a Libtayo dose, call your health care provider right away to reschedule.
How Well Does Libtayo Work for NSCLC?
Libtayo was approved by the FDA for treating NSCLC based on clinical trials that looked at how well it worked to treat the cancer.
In the EMPOWER-Lung 1 clinical trial, people received either Libtayo or platinum-based chemotherapy as an initial treatment of their NSCLC that had a PD-L1 expression of at least 50%. The clinical trial included 563 people, with 283 receiving Libtayo. They were followed to see how long it took for their lung cancer to progress, meaning that the cancer grew or spread. This measurement is called progression-free survival. The median progression-free survival was 8.2 months for people who received Libtayo, compared to 5.7 months for the people who received chemotherapy. This means that half of the people who received Libtayo did not have their cancer progress for at least 8.2 months, compared to 5.7 months for people who received chemotherapy. The races and ethnicities of the people in the clinical trial were not reported, but the clinical trial enrolled people from all around the world, including Europe and Asia, with most of the people enrolled in Europe.
In the EMPOWER-Lung 3 clinical trial, people received either Libtayo plus platinum-based chemotherapy or a placebo plus platinum-based chemotherapy as an initial treatment of their NSCLC. A placebo is used in clinical trials as a control so that the potential benefit of a new medicine in a group of people can be compared in a similar group of people who did not receive the new medicine. The clinical trial included 466 people, with 312 receiving Libtayo. The racial and ethnic breakdown of people in this clinical trial was not reported. They were followed to see how long they survived after starting to use the medicine. This measurement is called overall survival. The median overall survival was 21.9 months for people who received Libtayo plus chemotherapy, compared to 13 months for the people who received a placebo plus chemotherapy. This means that half of the people who received Libtayo plus chemotherapy were still alive after 21.9 months, compared to 13 months for people who only received chemotherapy.
How Will My Progress Be Monitored?
Libtayo will start working as soon as you receive your first dose. Your health care provider will usually do a scan to see how your cancer is responding to the treatment six weeks after you start receiving infusions of Libtayo. They may choose to do the scan earlier or later than six weeks.
Your health care provider will also do regular bloodwork to monitor how Libtayo is working in your body. These tests will monitor your blood counts, such as white blood cells, neutrophils, and platelets, so that your health care provider knows that it is safe for you to continue to use Libtayo. If you have certain side effects such as a cough, your health care provider may do tests to make sure it is safe for you to continue to use Libtayo.
It is important that you attend all appointments with your health care provider so they can make sure Libtayo is safe for you. If you miss an appointment, call your health care provider right away to reschedule.
How Can I Prevent and Manage Side Effects?
Side effects are common with medicines that are used to treat cancer, including Libtayo. It is important to tell your health care provider about any side effects you have during or after your Libtayo infusion. They can help to find out if your side effects are serious and need treatment or provide more information to help you manage or prevent the side effects.
You can ask your health care provider what else you can do to prevent or treat common side effects. For example, you can help to prevent and treat diarrhea by staying hydrated and eating foods that are easy to digest. They may also recommend you keep certain over-the-counter medicines on hand to treat common side effects like diarrhea and what to do if you have severe diarrhea. They will also tell you how to watch for severe side effects, such as lung problems or heart problems, and what to do if you have these side effects.
If you have certain side effects while you use Libtayo, your health care provider may need to pause your doses of medicine, or even stop your medicine altogether. This will depend on the side effect you have, how severe it is, and what treatment it needs. If your medicine is paused, it is possible that your health care provider will restart the medicine at the same dose or need to eventually stop the medicine once your side effect is treated and gets better.
What Are Other Unique Considerations to Be Aware Of?
Libtayo can cause your immune system to attack and harm organs and tissues in your body that are working normally. This can be serious and even life-threatening. It can cause many issues in your body, such as problems with your lungs, hormones, skin, eyes, and heart, along with problems with organs like your kidneys and liver. It is important that you talk with your health care provider before starting to use Libtayo and tell them about any side effects you have while using the medicine.
Libtayo can harm an unborn baby. If you are able to get pregnant, your health care provider will likely have you do a pregnancy test before you start to use Libtayo to ensure you are not pregnant. You will need to use effective birth control while using Libtayo and for at least four months after your last dose. It is not known if Libtayo passes into breast milk, but you should not breastfeed while using Libtayo and for at least four months after your last dose.
Is There Any Cost Assistance Available?
The maker of Libtayo has a financial assistance program and may be able to offer coupons or savings for Libtayo
