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Opdivo plus Yervoy Immunotherapy Combination Approved for Patients with Liver Cancer

January 2021 – A Patient Guide to Recent FDA-Approved Oncology Drugs

Opdivo (nivolumab) given in combination with Yervoy (ipilimumab) is now approved by the Food and Drug Administration (FDA) for the treatment of patients with liver cancer, or hepatocellular carcinoma (HCC), who have already been treated with the chemotherapy drug sorafenib. In 2017, Opdivo was approved on its own for the treatment of patients with liver cancer, but the immunotherapy combination containing Opdivo and Yervoy now offers another, and potentially more effective, treatment option for patients with this aggressive type of cancer.

Andrea Wilson, president and founder of Blue Faery: The Adrienne Wilson Liver Cancer Association, said: “The incidence of liver cancer is rising in the United States, and HCC is the most common and aggressive form of the disease. Today’s approval provides a new option for patients with HCC previously treated with sorafenib, giving the community more hope.”

Opdivo and Yervoy are both immunotherapy drugs. Immunotherapy is a type of treatment that harnesses the body’s own immune system to fight cancer cells. Although this type of treatment has led to breakthroughs in survival for many types of cancer, it can also cause the immune system to attack normal organs and tissues in any area of the body, potentially leading to a whole host

of side effects. These side effects are known as immune-mediated adverse reactions (or immune-mediated side effects), which can be serious and even lead to death. These side effects may happen anytime during treatment, or even weeks or months after treatment has ended. Importantly, more than 1 of these side effects may occur at the same time.

This is the first and only dual immunotherapy treatment approved in the setting of liver cancer, but the combo is already approved to treat several other types of cancer. But it is important to note that when immunotherapies are combined, like in the case of Opdivo and Yervoy, side effects may occur more often.

For the treatment of liver cancer, Opdivo is given at a dose of 1 mg/kg through intravenous (IV) injection over 30 minutes, and Yervoy is given at a dose of 3 mg/kg IV over 30 minutes, every 3 weeks for a total of 4 doses. After 4 doses have been given, treatment continues with Opdivo alone (every 2 weeks or 4 weeks depending on the dose) until either the cancer progresses or side effects are too severe to continue treatment. Patients’ healthcare providers will decide how many treatments they need.

Exciting Clinical Trial Results

Promising results were seen in an ongoing clinical trial of patients who were treated with Opdivo and Yervoy for their liver cancer after their cancer got worse on sorafenib, or they could not tolerate its side effects.

Clinical trials are research studies performed on people to test the safety and effectiveness of new drugs or treatments. It is important to note that patients involved in cancer clinical trials are not “guinea pigs.” They are never given a placebo, but instead are given either the most effective available treatment for their cancer or one that doctors and researchers think might be even better. This is typically a new drug, a combination of drugs, or a different way of using established therapies; in this case, it was the combination of Opdivo and Yervoy.

In the trial called CheckMate-040, the drug combo achieved a minimum 30% reduction in the tumors of 33% of patients, and 8% saw a complete disappearance of their tumors. After about a year and a half on the drug regimen, 1 of 2 patients in the trial were still responding to treatment, and their tumors were continuing to shrink.

The most common side effects in the trial (reported in more than 20% of patients) were rash (53%), itchiness (53%), pain affecting the bones, muscles, ligaments, tendons, and nerves (41%), diarrhea (39%), cough (37%), decreased appetite (35%), feeling tired (27%), fever (27%), stomach pain (22%), headache (22%), nausea (20%), dizziness (20%), underactive thyroid (20%), and weight loss (20%).

Side Effects of Opdivo/Yervoy

Opdivo may lead to immune-mediated pneumonitis (lung problems, including new or worsening cough, chest pain, or shortness of breath), colitis (intestinal problems, including diarrhea, blood in the stool, or severe stomach pain), hepatitis (liver problems characterized by symptoms like yellowing of the skin or whites of the eyes, or severe nausea or vomiting), hormone gland problems, especially involving the thyroid, pituitary, and adrenal glands, and pancreas (signs and symptoms that the hormone glands are not working properly include headaches that will not go away, extreme tiredness, and weight gain or weight loss), kidney problems, skin problems (including rash and blistering), inflammation of the brain, and problems in other organs.

Yervoy can also result in severe and deadly immune-mediated adverse reactions, the most common being intestinal problems (including diarrhea, blood in the stool, or severe stomach pain), hepatitis (liver problems that can lead to liver failure), dermatitis (also known as eczema, characterized by itchy, dry skin or a rash on swollen, reddened skin), neuropathy (weakness, numbness, and pain from nerve damage, usually in the hands and feet), and hormone problems including hyperthyroidism (overactive thyroid) and hypothyroidism (underactive thyroid).

Patients taking Opdivo/Yervoy may experience other adverse reactions, including allergic reactions to the IV infusion (characterized by chills, shaking, itching, or rash). This drug combo can cause harm to an unborn baby and can lead to a miscarriage, so women who are pregnant or plan to become pregnant should not take this drug combination, and women who can become pregnant should take effective birth control during treatment and for at least 5 months after the last dose. The same goes for breastfeeding: patients should not breastfeed while receiving this treatment.

Before taking Opdivo/Yervoy, patients should tell their doctor about any medical conditions, including any immune system problems (like Crohn’s disease, ulcerative colitis, or lupus), liver problems, or breathing problems, if they have a condition that affects their nervous system, or if they have had an organ transplant. Patients should also tell their healthcare provider about any prescription and over-the-counter medicines they take, including vitamins and herbal supplements.

Getting medical treatment right away may keep these problems from becoming more serious, so patients should monitor their own side effects in addition to getting checked regularly by their doctor. Corticosteroid or hormone replacement medicines may be necessary to treat some of the side effects associated with these medications, but in some cases of very severe side effects, treatment may have to be delayed or completely stopped.

Sarlis Says

The combination of Opdivo plus Yervoy is the first and only dual immunotherapy treatment approved in patients with liver cancer in the second-line setting after previous treatment with sorafenib. It offers considerable flexibility in a complex management landscape.

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