Tagrisso (osimertinib) is a medicine used for certain types of non-small-cell lung cancer (NSCLC) that have an epidermal growth factor receptor (EGFR) mutation.
How Does Tagrisso Work for Lung Cancer?
EGFR is a protein on the surface of cells and helps cells to grow and multiply. Tagrisso is a type of medicine called a kinase inhibitor. It attaches to the mutant EGFR protein and turns the protein off. This causes EGFR to quit sending the signal to cells to grow and multiply, which causes the cells to die and can cause tumors to shrink in size.
What Kinds of Lung Cancer Does Tagrisso Treat?
Lung cancer that has an EGFR mutation may be able to be treated by Tagrisso. It may be used in certain people by itself before or after surgery to remove a tumor or in combination with other medicines to treat lung cancer.
How Do I Use Tagrisso for Lung Cancer?
Tagrisso is a tablet that is swallowed. You will take your Tagrisso dose once a day with or without food. You should try to take it around the same time every day. Depending on the treatments you have previously tried for your lung cancer, you may take Tagrisso for 3 years or for as long as possible. If you have certain side effects, your health care provider might change your dose, pause your doses, or stop them all together. Your health care provider will talk with you about how long you can expect to take Tagrisso.
How Well Does Tagrisso Work for Lung Cancer?
The FDA approved Tagrisso based on clinical trials for EGFR-mutated lung cancer in several different scenarios.
Tagrisso was studied in people who had lung cancer with an EGFR mutation who had previously had surgery to remove their tumor and may or may not have had chemotherapy. Tagrisso was compared with a placebo treatment in a clinical trial called ADAURA. (A placebo is a fake treatment that is given that has no medicine.) Tagrisso worked better in treating EGFR mutated lung cancer than the placebo. The clinical trial included 682 people who used one of the two treatments. They were followed to see how long it took for their lung cancer to return after having surgery or chemotherapy. This measurement was called disease-free survival (DFS). The median DFS was not reached, meaning more than 50% of patients were still on treatment without cancer when the data was analyzed, compared to 27.5 months for placebo. This means that half of the people who received placebo had disease return within 27.5 months of starting treatment.
This clinical trial also looked at overall survival (OS), which looked at how long people were alive after starting treatment with Tagrisso or placebo. The OS was reported as a 5-year survival rate, meaning how many people were still alive 5 years after starting treatment. The 5-year OS in people who received Tagrisso was 88% compared to 78% for the people who received placebo. This means that at 5 years, 88% of people who received Tagrisso were still alive.
Tagrisso was studied in people who had EGFR-mutated lung cancer who had not received chemotherapy for lung cancer that was metastatic. Tagrisso was compared against another kinase inhibitor targeting EGFR in a clinical trial called FLAURA. Tagrisso worked better in treating EGFR-mutated lung cancer than the other medicines (erlotinib or gefitinib, which are also kinase inhibitors). The clinical trial included 556 people who used either Tagrisso or another kinase inhibitor treatment. 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 (PFS). The median PFS was 18.9 months for Tagrisso compared to 10.2 months for one of the other treatments. This means that half of the patients who took Tagrisso did not have their cancer progress for at least 18.9 months.
This study also looked at median overall survival, which measured how long half of the people in the study who received a certain medicine survived after starting to use the medicine. People who took Tagrisso in the study had a median overall survival of 38.6 months, while people who used one of the other treatments had a median overall survival of 31.8 months.
Tagrisso was studied in combination with other medicines, pemetrexed and a platinum-based chemotherapy, in people who had EGFR-mutated lung cancer who had not received chemotherapy for lung cancer that was advanced. The combination of Tagrisso with pemetrexed and chemotherapy was compared against Tagrisso alone in a clinical trial called FLAURA2. The Tagrisso combination worked better at treating advanced EGFR-mutated lung cancer than Tagrisso alone. The clinical trial included 557 people who used either Tagrisso with other medications or just Tagrisso. They were followed to see the progression-free survival (PFS). The median PFS was 25.5 months for Tagrisso in combination with other medicines compared to 16.7 months for Tagrisso alone. This means that half of the patients who took Tagrisso in combination with other medicines did not have their cancer progress for at least 25.5 months.
Tagrisso was also studied in people who had EGFR mutated lung cancer who had received at least one previous treatment that had to include a treatment targeted at EGFR. All of the people in this trial had to have a specific EGFR mutation known as T790M and have NSCLC that had spread to other parts of the body (known as metastatic cancer). Tagrisso was compared against chemotherapy in a clinical trial called AURA3. Tagrisso worked better in treating EGFR-mutated lung cancer that had previously been treated than chemotherapy. The clinical trial included 419 people who used either Tagrisso or chemotherapy. They were followed to see the progression-free survival (PFS). The median PFS was 10.1 months for Tagrisso compared to 4.4 months for chemotherapy. This means that half of the patients who took Tagrisso did not have their cancer progress for at least 10.1 months.
This study also looked at median overall survival, which measured how long half of the people in the study who received a certain medicine survived after starting to use the medicine. People who took Tagrisso in the study had a median overall survival of 26.8 months while people who used chemotherapy had a median overall survival of 22.5 months.
How Will My Progress Be Monitored?
Tagrisso will start working as soon as you take your first dose. Your health care provider will usually do a scan to see how your cancer is responding to the treatment 6 weeks after you start taking the medicine. They may choose to do the scan earlier or later than 6 weeks if they believe it is the right choice for you.
Your health care provider will usually do regular blood tests or other tests to monitor how Tagrisso 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 you can safely continue to take Tagrisso. If you have certain side effects such as a cough or shortness of breath, your health care provider may do additional tests to make sure it is safe for you to continue to take Tagrisso.
How Can I Prevent and Manage Side Effects?
Side effects are common with medicines that treat cancer, including Tagrisso. It is important to tell your health care provider about any side effects you have during or after taking Tagrisso. They can help to determine if your side effects are serious or provide more information to help you manage the side effects.
Your health care provider may instruct you to take certain medicines if you have certain side effects. For example, if you have diarrhea while taking Tagrisso, your health care provider may suggest that you drink electrolyte replacement liquids, increase the amount of fluids you drink, and take an anti-diarrheal medication.
If you are taking Tagrisso along with pemetrexed and platinum-based chemotherapy, your health care provider will usually instruct you to take certain medicines before your infusion to help prevent the most common side effects: nausea and vomiting. These are usually caused by the chemotherapy infusions. It is important to follow their instructions. In addition to taking any medicines before your infusion, 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 nausea, vomiting, and diarrhea by eating bland foods and having multiple small meals throughout the day instead of three large meals.
If you have certain side effects while you take Tagrisso, your health care provider may need to change your dose of medicine, pause your infusions, or even stop your medicine altogether. This will depend on the side effect you experience and how severe it is and what treatment it needs. If your Tagrisso dose needs to be lowered, the medicine will continue to work in your body. If your medicine is paused, your health care provider might restart the medication at the same dose or at a lower dose once your side effect gets better.
What Are Some Other Unique Considerations to Be Aware Of?
Tagrisso can cause harm to an unborn baby. Your health care provider will discuss options for contraception while you take Tagrisso. If you can become pregnant, it is important that you use effective contraception for 6 weeks after your final dose of Tagrisso. If you are male or were assigned male at birth and have a partner who can get pregnant, it is important to use effective contraception for 4 months after your final dose of Tagrisso. If you and your partner are or are planning to become pregnant, talk with your health care provider about your options.
Tagrisso can cause very serious side effects. These include lung problems, heart problems, eye problems, skin problems, and blood and bone marrow problems. It’s important to tell your health care provider if you experience any side effects but especially if you have a cough, shortness of breath, racing heartbeat, blurred vision, fever, or blistering and peeling of your skin.
Is there any cost assistance available?
The manufacturer of Tagrisso has a copay savings program for eligible people.
