Opdivo is a type of cancer treatment called immunotherapy. Immunotherapy works by using the body's immune system to fight cancer cells. Opdivo is designed to help the immune system fight a type of lung cancer called non-small-cell lung cancer (NSCLC). It is the first immunotherapy medicine to be approved to treat lung cancer.
How Does Opdivo Work for Lung Cancer?
Some cancer cells have what are called checkpoint proteins on their cell surface. The immune cells in our bodies also have proteins on their surface. When these proteins bind to each other, the T cells in our body get turned “off,” which stops them from killing cancer cells. Opdivo acts on proteins on the T cell called PD-1 and prevents these proteins from binding to PD-1 proteins on the tumor cell. This turns the T cell back “on” and allows it to do its job of attacking and killing the tumor cell.
What Kinds of Lung Cancer Does Opdivo Treat?
- Early-stage NSCLC that can be removed by surgery (resectable).
- NSCLC that is advanced or has spread to other parts of your body (metastatic) and is positive for the PDL-1 protein.
- NSCLC that is metastatic or has come back during or after treatment with chemotherapy.
How Will I Get Opdivo?
Opdivo is put into a vein as an intravenous (IV) infusion. It will be given to you by a health care provider in a health care setting. The dose of Opdivo is 360 milligrams given every 3 weeks or every 6 weeks, 240 milligrams given every 2 weeks, or 480 milligrams given every 4 weeks. Your health care provider may stop Opdivo if your cancer gets worse (progresses) or you have side effects that prevent you from tolerating the medicine.
How Well Does Opdivo Work for Lung Cancer?
The FDA approved Opdivo for NSCLC based on several clinical trials.
Opdivo was studied in people who had never received treatment for their cancer before and had NSCLC that could be removed by surgery. People in this trial received either Opdivo plus chemotherapy or chemotherapy alone. There were 358 people in this study; half of them received Opdivo and chemotherapy, and the other half received chemotherapy alone. The median age in each group was about 65, and around 71% of patients in each group were male. This study looked at event-free survival, which is how long after their treatment people did not experience progression, recurrence of their cancer, or death. The median event-free survival was 31.6 months in the Opdivo plus chemotherapy group and 20.8 months in the chemotherapy alone group. This means that people that received Opdivo and chemotherapy lived significantly longer without their cancer growing than those who got chemotherapy alone.
Researchers also looked at whether there were any signs of cancer in tissue samples after treatment, a measure known as pathological complete response. They found that the percentage of patients achieving a pathological complete response was higher in the Opdivo plus chemotherapy group (24%) compared to the chemotherapy-only group (approximately 2%). This means that 24% of people who got Opdivo and chemotherapy had no signs of cancer in their tissue samples after treatment.
Opdivo was studied in people with metastatic or recurrent NSCLC and a positive PDL-1 protein. In this trial, people received either Opdivo plus another immunotherapy called Yervoy, Opdivo alone, or chemotherapy. People were included if they had not received any other treatment for their advanced or metastatic NSCLC. This study looked at overall survival between the Opdivo plus Yervoy and chemotherapy groups. Overall survival measures how long people in the study survived after receiving their treatment. There were 1,189 people in this study, and they were evenly split among the three treatment groups. The median age for the study was 64, and there were more males than females (65%). Overall survival was 17.1 months in people who got Opdivo plus Yervoy and 14.9 months in people who got chemotherapy. This means the rate of overall survival was significantly higher among the patients who received Opdivo plus Yervoy than for those who received chemotherapy.
Opdivo was also studied in people with metastatic or recurrent NSCLC that was either positive or negative for PDL-1. In this study, people received Opdivo plus Yervoy in combination with chemotherapy or chemotherapy alone. This study looked at overall survival. There were 719 patients in the study, and they were evenly split between the two treatment groups. The median age was 65, with 51% of patients 65 or older and 10% of patients 75 or older. Most patients were male (70%). People getting Opdivo plus Yervoy and chemotherapy had a median survival of 14.1 months, while people getting chemotherapy alone had a median overall survival of 10.1 months. This means people in the Opdivo group lived significantly longer than those in the chemotherapy group.
Opdivo was studied in people with metastatic NSCLC that grew during treatment with chemotherapy or came back after their treatment. People were included in this study if they have received one prior platinum-based chemotherapy for their NSCLC. This study compared Opdivo to a chemotherapy called docetaxel. There were 272 people in this study, and they were split evenly between the two study groups. The study looked at overall survival, which measured how long people lived after they started their medicine. The people who got Opdivo had a median overall survival of 9.2 months, and the people who got docetaxel had a median overall survival of 6 months. This means that people in the Opdivo group lived longer than people who got docetaxel.
What Are Some Unique Considerations to Be Aware Of?
Opdivo can cause harm to an unborn baby. Your health care provider will discuss options for contraception while you take Opdivo. You should use an effective method of birth control while you are receiving Opdivo and for 5 months after your last dose. If you and your partner are or are planning to become pregnant, talk with your health care provider about your options. Opdivo may pass into your breastmilk if you are breastfeeding. You should not breastfeed while you are getting Opdivo and for 5 months after your last dose.
Opdivo can cause very serious side effects. These include lung problems, intestinal problems, liver problems, hormone gland problems, kidney problems, and skin problems. Problems can also happen in other organs and tissues. It is important to tell your health care provider as soon as you experience any side effects including chest pain, fast heartbeat, shortness of breath, confusion, double or blurry vision, severe muscle pains, or bruising more easily than usual.
What Are the Possible Side Effects of Opdivo, and How Can I Prevent or Manage Them?
Opdivo can cause severe side effects including skin reactions, diarrhea, and high blood sugar levels.
Contact your health care provider right away if you notice any new rash or existing rash that is getting worse; reddening of the skin; fever; blistering of the lips, eyes, or mouth; blisters on the skin; skin peeling; or dry skin. They will decide whether you should continue or stop taking Opdivo. They will also recommend creams or antihistamines to help with your rash and itchiness. Skin reactions are the most common side effect of Opdivo and can happen at any time after you start taking it and even after you stop. You may also be given a corticosteroid to treat your rash.
Notify your health care provider as soon as diarrhea starts, and start taking your diarrhea medicine. Drink more fluids to avoid losing too much of your body water (dehydration). Mild to moderate diarrhea can happen any time after you start taking Opdivo. Your health care provider may treat you with corticosteroids if your diarrhea is mild or moderate. If you have severe diarrhea, you may receive another immunosuppressive treatment given to you as an intravenous infusion.
Your health care provider will tell you if you need to monitor your fasting blood sugar levels (blood sugar after an overnight fast) while you are taking Opdivo. Contact your health care provider if you notice your blood sugar rising or start having symptoms like feeling more thirsty than usual, needing to pee more often or in greater amounts, or have blurred vision or headaches. Your health care provider will have you get lab tests regularly and decide how to best manage your blood sugar levels.
If you’re receiving Opdivo alongside platinum-based chemotherapy, your health care provider will typically recommend taking certain medications before your infusion to help prevent common side effects like nausea and vomiting, which are usually caused by the chemotherapy. It’s important to follow their instructions carefully. In addition to taking prescribed medications, you can ask your health care provider for additional strategies to manage or prevent side effects. For example, eating bland foods and having several small meals throughout the day, avoiding greasy foods, and drinking only small amounts of clear liquids can help manage nausea and vomiting.
If you have certain side effects while you take Opdivo, your health care provider may need to change how often you get infusions, pause your infusions, or even stop your medicine altogether. This will depend on how severe the side effect is and what type of treatment it requires.
These are not all the possible side effects of Opdivo. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can also report side effects to the FDA at 800-FDA-1088 (800-332-1088).
How Do I Know if Opdivo Is Working?
Your health care provider will regularly check how well Opdivo is working for your cancer through looking at results of tests such as blood tests and CT scans or MRI scans. You may notice improvements within a few weeks to months after starting Opdivo. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Opdivo Stay in My System?
Opdivo remains in the body for several months after the last dose. Even after stopping Opdivo, immune-related side effects may continue. Regular follow-up is essential to manage any lingering side effects and ensure a smooth transition off the treatment.
How Can I Get Opdivo?
Your cancer doctor (oncologist) will arrange for you to receive Opdivo in a health care setting, such as a hospital or infusion center. If you need support paying for Opdivo, the drugmaker may be able to help you. Check out their BMS Access Support program at www.bmsaccesssupport.com/patient to learn more about their patient assistance program or to ask your questions about insurance coverage and out-of-pocket costs. You can also contact the drugmaker at 800-861-0048.
