OPDIVO® (nivolumab) is a prescription medicine and may be used alone or in combination with YERVOY® (ipilimumab) to treat melanoma, a type of skin cancer, that has spread or cannot be removed by surgery (advanced melanoma).
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous use.
Serious Side Effects
OPDIVO and YERVOY are associated with a number of serious risks that may impact a patient’s ability to work, function, and participate in activities of daily living. Some of these risks include problems that can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; and severe infusion reactions. Additional serious side effects observed during a separate study of YERVOY alone include: nerve problems that can lead to paralysis; and eye problems.
Study Design and Results
OPDIVO, used in combination with YERVOY or as a single agent, was approved by the FDA for this use based on a clinical trial of 945 patients with previously untreated, unresectable or metastatic melanoma, in which 314 patients received treatment with the OPDIVO + YERVOY combination, 316 patients received OPDIVO alone and 315 patients received YERVOY alone.
In the primary analysis of the trial, OPDIVO + YERVOY and OPDIVO reduced the risk of the cancer spreading, growing, or getting worse by 58% and 43%, respectively, compared to YERVOY at 9 months.
Half of the patients on OPDIVO + YERVOY went 11.5 months and half of the patients on OPDIVO went 6.9 months without the cancer spreading, growing, or getting worse versus 2.9 months with YERVOY. OPDIVO + YERVOY and OPDIVO reduced the risk of dying by 45% and 37% compared to YERVOY at 28 months. In a follow-up analysis of this trial, half the patients treated with YERVOY were alive at 19.9 months while half the patients treated with OPDIVO were alive at 36.9 months and more than half of patients treated with OPDIVO + YERVOY were alive.
OPDIVO + YERVOY and OPDIVO have also been shown to reduce or shrink tumors. Among patients treated with OPDIVO + YERVOY or OPDIVO, respectively, 50% and 40% of all tumors shrank or disappeared completely (41% of tumors shrank while 9% disappeared completely with OPDIVO + YERVOY; 31% of tumors shrank while 9% disappeared completely with OPDIVO) at 9 months compared to 14% for patients treated with YERVOY (12% of tumors shrank while 2% disappeared completely).
The efficacy of OPDIVO + YERVOY cannot be compared to OPDIVO.
Common Side Effects
The most common side effects of OPDIVO + YERVOY include: feeling tired; rash; diarrhea; nausea; fever; pain in muscle, bones, and joints; upper respiratory tract infection; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of OPDIVO include: feeling tired; rash; pain in muscles, bones, and joints; itchy skin; diarrhea; nausea; weakness; cough; vomiting; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; abdominal pain. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.
Please see additional safety information below.