(BPT) - When most people think of advanced melanoma treatment, their first thought likely includes chemotherapy, radiation and surgery. Immuno-oncology (IO), also known as immunotherapy, has changed how advanced melanoma can be treated.

Unlike chemotherapy, radiation and surgery, which directly target the tumor, IO uses medication that is designed to leverage the body's own immune system to help recognize and target tumor cells. IO has the potential to help stop tumor growth or shrink tumors, and it can come in two forms: monotherapy (one immunotherapy) or dual IO (two immunotherapies working together).

Finding an Appropriate Treatment

The first dual IO medication for the first-line treatment of metastatic melanoma (the deadliest form of skin cancer) was approved nearly 10 years ago. Since then, dual IO has become a critical pillar in advanced melanoma treatment. One treatment option in advanced melanoma for adults and children 12 years of age or older is Opdualag™ (nivolumab and relatlimab-rmbw), which is designed to work by connecting to tired T cells and activating them so they can help the immune system attack cancer. All therapies have the potential to result in adverse reactions. See below for Important Safety Information on Opdualag.

Receiving an advanced melanoma diagnosis can be overwhelming, especially if it's uncharted territory. However, understanding others' experiences may help patients better navigate a diagnosis.

In 2022, Terry* was diagnosed with metastatic melanoma. As a U.S. veteran, an avid rider of his electric bike and someone who loves to travel and spend time with friends, Terry feared for what this diagnosis meant. He was concerned about the treatment journey ahead. After discussing treatment options with his healthcare team, Terry's doctor recommended that he receive Opdualag.

Hear more from Terry about his experience and why dual IO was the right treatment for him, as well as expertise from Hussein A. Tawbi, MD, PhD, Melanoma Medical Oncologist, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center,** about navigating an advanced melanoma diagnosis and the importance of continued innovation.

Based on your experience with melanoma, how has your treatment journey impacted your life?

Terry: My diagnosis changed my life.

I'm honored that I was the first patient at the Veterans Affairs (VA) to receive Opdualag after it was approved by the FDA. The results were impactful for me, and treatment was mostly manageable where I experienced a little fatigue, afternoon tiredness, a rash on the back of my neck and a few itchy red blotches on my arm and chest. I'm glad I talked to my doctor about treatment options.

Terry's results may not be typical. Opdualag may not work for everyone. Individual results may vary.

Why is it important that innovation continues for the treatment of advanced melanoma?

Dr. Tawbi: In the U.S., it is estimated that more than 100,000 new melanomas will be diagnosed in 2024 alone with advanced melanoma representing about 10% of all cases. These statistics stress the urgency for continued scientific innovations, such as dual IO, in cancer treatment.

Based on your personal experience, what would you tell someone who has been diagnosed with melanoma?

Terry: My biggest piece of advice is to find a doctor you trust and can have open and honest conversations with. Together, you and your doctor can develop a personalized treatment plan that you both feel is the right option for you.

Dr. Tawbi, what is your advice for newly diagnosed patients?

Dr. Tawbi: I encourage patients to promptly start a dialogue with their doctor to become more informed about the condition. It's also important to lean on resources outside of the doctor's office, such as family, friends and advocacy organizations. The more patients know about their condition, the more empowered they'll feel to advocate for themselves and engage in treatment decision-making conversations with their doctors.

To learn more about Opdualag, visit www.opdualag.com and speak with your doctor.

*Terry is an actual patient who has been compensated by Bristol Myers Squibb for his role in the article.

**Dr. Tawbi has previously served as a clinical trial investigator and scientific advisor to Bristol Myers Squibb.

INDICATION:

Opdualag™ (nivolumab and relatlimab-rmbw) is a prescription medicine used to treat adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma). It is not known if Opdualag is safe and effective when used in children younger than 12 years of age or older who weigh less than 88 pounds (40 kg), or in children younger than 12 years of age.

Important Safety Information for Opdualag (nivolumab and relatlimab-rmbw)

What is the most important information I should know about Opdualag?

Opdualag is a medicine that may treat a type of skin cancer called melanoma by working with your immune system. Opdualag 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 can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

• Lung problems: new or worsening cough; shortness of breath; chest pain
• Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness
• Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
• Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
• Kidney problems: decrease in your amount of urine; blood in your urine; swelling in your ankles; loss of appetite
• Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in the mouth or nose, throat, or genital area
• Heart Problems: new or worse chest pain; irregular heartbeat or feel like your heart is racing; shortness of breath; tiredness; swelling in your ankles

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with Opdualag. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

• Confusion; sleepiness; memory problems; changes in mood or behavior; stiff neck; balance problems; tingling or numbness of the arms or legs
• Double vision; blurry vision; sensitivity to light; eye pain; changes in eyesight
• Persistent or severe muscle pain or weakness; muscle cramps
• Low red blood cells; bruising

Getting medical help right away may help keep these problems from becoming more serious. Your healthcare team will check you for these problems during treatment with Opdualag. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop your treatment with Opdualag if you have severe side effects.

Possible side effects of Opdualag

Opdualag can cause serious side effects, including:

• See "What is the most important information I should know about Opdualag?"
• Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of Opdualag: chills or shaking; itching or rash; flushing; shortness of breath; dizziness; feel like passing out; fever; back or neck pain
• Complications of stem cell transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Opdualag. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

The most common side effects of Opdualag include: muscle and bone pain; tiredness; decreased red blood cell and white blood cell counts; increased liver function test results; rash; itching, diarrhea; decreased salt (sodium) in your blood.

These are not all the possible side effects of Opdualag. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before receiving Opdualag, tell your healthcare provider 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 a condition that affects your nervous system, such as myasthenia gravis, or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Opdualag can harm your unborn baby
  Females who are able to become pregnant:

• your healthcare provider should do a pregnancy test before you start receiving Opdualag
• you should use an effective method of birth control during and for at least 5 months after the last dose of Opdualag. 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 during treatment with Opdualag
• are breastfeeding or plan to breastfeed. It is not known if Opdualag passes into your breast milk. Do not breastfeed during treatment with Opdualag and for 5 months after the last dose of Opdualag

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see U.S. Full Prescribing Information and Medication Guide for Opdualag.

© 2024 Bristol-Myers Squibb Company.

Opdualag™ and the related logo are trademarks of Bristol-Myers Squibb Company.

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