Opdualag is an innovative cancer treatment designed to help the immune system fight advanced melanoma. It is the first medicine ever to combine two immunotherapy agents into one single product. Immunotherapy works by using the body's own immune system to fight off cancer cells. The development of immunotherapy has changed the way that advanced melanoma is treated.
Below you’ll find common questions and answers about Opdualag to help decide whether it’s right for you.
How Does Opdualag Work for Advanced Melanoma?
Some cancer cells have what are called checkpoint proteins on their surface. The immune cells in our body 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. Opdualag prevents these proteins from binding to each other, which turns the T cell back “on” and allows it to do its job of attacking and killing the tumor cell.
Opdualag contains two active ingredients: nivolumab and relatlimab. Each of these ingredients blocks a different protein on the T cell. Relatlimab blocks the LAG-3 protein, while nivolumab blocks the PD-1 protein. By blocking these proteins, Opdualag reactivates T cells, making them more able to destroy melanoma cells.
Is Opdualag Right for Me?
Opdualag may be the right choice for you if:
- Your cancer is advanced or has spread to other parts of your body (metastatic).
- You have cancer that cannot be removed by surgery (unresectable).
How Will I Get Opdualag?
Opdualag 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 Opdualag is a combination of 480 milligrams of nivolumab and 160 milligrams of relatlimab once every 4 weeks. Your health care provider may stop Opdualag if your cancer gets worse (progresses) or you have side effects that prevent you from tolerating the medicine.
How Was Opdualag Studied for Melanoma?
One clinical study was done to see if the combination of nivolumab and relatlimab was safe and effective for treating melanoma.
To learn this, the researchers measured how long it took for the people in the study to experience worsening of cancer. This is called “progression-free survival” and shows how well a medicine controls a disease.
Researchers also measured how long the people in the study lived in general. This is called “overall survival” and shows how much the medicine helps the people in the study live longer.
Also, researchers looked at the quality of life of the people in the study.
What medicines did the people in the study take?
In this study, the combination of nivolumab and relatlimab was compared to nivolumab alone. Half the people got relatlimab-nivolumab, and the other half got nivolumab alone. People in the study did not know which medicine they were getting.
The main question this study wanted to answer was:
How well does nivolumab and relatlimab work, compared to nivolumab alone?
Who was included in the study?
To take part in the study, people had to:
- Be at least 12 years old
- Have confirmed stage III (unresectable) or stage IV melanoma
- Have not had prior systemic anticancer therapy for unresectable or metastatic melanoma. Certain therapies were allowed if they were given more than 6 months ago.
- Have finished radiation at least 2 weeks before getting study medicine
Who was excluded from the study?
People could not be in this study if they:
- Had active brain metastasis or leptomeningeal metastasis
- Had uveal (ocular) melanoma
- Had been treated with medicines similar to those given in the study
- Had another prior cancer within the previous 3 years, except for locally curable cancers that had been apparently cured
- Had an active, known, or suspected autoimmune disease
- Had a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of the start of trial treatment
- Were pregnant or breastfeeding
What was the study population?
- Everyone had unresectable melanoma and LAG-3 and PD-1 proteins.
- About 41% were female.
- The age range was 20 to 94 years, and the median age was about 63 years old.
- Most of the people studied (92%) did not receive any prior treatment for their cancer.
What Benefits Were Seen With Opdualag?
Progression-free survival: The people who got relatlimab-nivolumab lived without disease progression significantly longer than those who got nivolumab alone. The median progression-free survival in the relatlimab-nivolumab group was two times longer than that of the nivolumab group. A higher percentage of people responded to relatlimab-nivolumab (48%) compared to nivolumab alone (36%).
Overall survival: There was no significant difference between the two groups in the length of time people stayed alive.
Quality of life: The quality of life was about the same in each group in the trial.
Are There Any Reasons That I Should Not Take Opdualag?
Make sure your health care provider is aware of all of your past or current health conditions.
People with preexisting autoimmune diseases or those who have received prior immunotherapy should discuss potential risks with their health care provider. Considerations for fertility and pregnancy should also be discussed.
What Are the Possible Side Effects of Opdualag, and How Can I Prevent or Manage Them?
Common side effects of Opdualag include fatigue, rash, itching, and diarrhea.
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 Opdualag. They will also recommend creams or antihistamines to help with your rash and itchiness. Skin reactions are the most common side effect of Opdualag and can occur 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 your diarrhea medicines. 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 Opdualag. 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 IV.
These are not all the possible side effects of Opdualag. 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 Opdualag Is Working?
Your health care provider will regularly check how well Opdualag is working for your cancer through looking at results of tests such as blood tests and CT scans or MRI scans. Take Opdualag exactly as your health care provider tells you. Do not stop taking Opdualag unless your health care provider tells you.
People may begin to notice improvements within a few weeks to months after starting Opdualag. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Opdualag Stay in My System?
Opdualag remains in the body for several months after the last dose. Even after stopping Opdualag, 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 Opdualag?
Your cancer doctor (oncologist) will arrange for you to receive Opdualag in a health care setting, such as a hospital or infusion center.
If you need support paying for Opdualag, the drugmaker may be able to help you. Check out their BMS Access Support program at https://www.bmsaccesssupport.com/patient to learn more about their patient assistance program or to ask questions about insurance coverage and out-of-pocket costs. You can also contact the drugmaker at 800-861-0048.
