"Until Cancer, I thought I Was Invincible."
As a college student, John Stoffer* felt like everything was going right. He was enjoying his studies at the University of Alabama and preparing to take the MCAT to realize his dream of going to medical school. He also enjoyed spending time with his girlfriend and felt excited about the future.
“Balancing school and studying for the MCAT was challenging, but I was excited to finish my undergraduate degree,” Stoffer says. “I was also preparing to propose to my girlfriend, so it felt as if everything was falling into place.”
It was the beginning of the spring semester when he noticed a lump behind his right ear. He went to a doctor who prescribed him antibiotics and didn’t think much of it for the rest of the school year. By the time he returned home for the summer, Stoffer’s mother noticed that the lesion was growing and encouraged him to seek a second opinion. His new doctor recommended surgery, but he had no idea how his life was about to change.
“Until Cancer, I Thought I Was Invincible”
When Stoffer came out of surgery, his doctor informed him that the lesion was advanced melanoma, a type of skin cancer that had spread to other parts of his body. He was shocked. “Besides feeling like a tired college student, I felt healthy,” explains Stoffer. “Being so young, I never expected a cancer diagnosis. It was at that point I realized I wasn’t invincible.”
Melanoma is considered to be the most dangerous type of skin cancer, as it’s more likely to metastasize or spread to other parts of the body. While melanoma makes up less than 1% of all skin cancers, it is associated with the majority of skin cancer deaths. It is also one of the most common cancers in young adults and overall, men are at higher risk for being diagnosed.
Once the shock of his diagnosis dissipated, he immediately turned to what he needed to do to fight cancer. “I have an extremely supportive family who took time to help me process my emotions and then turned to helping me find the best care team and the right treatment option for me.”
Stoffer quickly found that his diagnosis didn’t have to change his life trajectory. He found a supportive oncologist who was willing to have an open conversation about his treatment goals and provide clear information on a path forward. “With the help of my girlfriend, family and care team, I was able to find ways to cope,” he says. “My faith and taking everything one step at a time gave me hope and strength to tackle this challenge.”
For Stoffer, this meant adjusting his plans without giving cancer full authority over his life. “Once I made the conscious decision to focus on living my life despite a cancer diagnosis, I felt empowered to continue my studies, apply to medical school and focus on the positive.”
A Combination Immunotherapy Approach to Treating Advanced Melanoma
With the support of his oncologist, John received treatment with Opdivo (nivolumab) + Yervoy (ipilimumab), a dual immunotherapy developed by Bristol Myers Squibb. Opdivo is a prescription medicine and may be used alone or in combination with Yervoy to treat melanoma 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 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-threating 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; severe infusion reactions; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Additional serious side effects observed during a separate study of Yervoy alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Please see additional safety information below.
Opdivo + Yervoy was studied in a clinical trial of 945 patients with previously untreated, unresectable or metastatic melanoma, in which 314 patients received treatment with Opdivo + Yervoy, 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 dying by 45% and 37% compared to Yervoy at 28 months. In addition, half the patients on Yervoy were alive at 19.9 months, compared to more than half being alive on Opdivo + Yervoy. At five years, a follow-up analysis showed twice as many patients were alive with Opdivo + Yervoy versus Yervoy alone: 52% of patients treated with Opdivo + Yervoy and 44% of patients treated with Opdivo alone were alive, compared to 26% of patients treated with Yervoy alone.
In a separate analysis of the trial, Opdivo + Yervoy and Opdivo reduced the risk of the melanoma 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.
In this follow-up analysis, data were also assessed across patient BRAF status. BRAF is a gene that encodes BRAF protein kinase, and mutations in this gene can lead to uncontrollable cell growth. At five years, 60% of BRAF-mutant (MT) and 48% of BRAF wild-type (WT) patients in the Opdivo + Yervoy arm – and 46% of BRAF MT and 43% of BRAF WT patients receiving Opdivo alone – were alive, respectively. The same analysis showed that 30% of BRAF MT and 25% of BRAF WT patients receiving Yervoy alone were alive at five years.
“Immunotherapy, including Opdivo + Yervoy, has helped patients with advanced melanoma live longer and has revolutionized the way we treat melanoma patients,” says Sunandana Chandra, M.D., Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL. “The presence of biomarkers is a topic that often comes up when discussing treatment. While some patients will get tested for the presence of certain biomarkers, including BRAF, treatment with Opdivo + Yervoy can be used regardless of their BRAF status.”
The efficacy of Opdivo + Yervoy cannot be compared to Opdivo. Opdivo + Yervoy will not work for everyone. Individual results may vary.
The most common side effects of Opdivo, when used in combination with Yervoy, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. The most common side effects of Opdivo when used alone 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; stomach-area (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.
“Advanced melanoma was historically associated with low survival rates and patients did not have many treatment options,” says Dr. Chandra. “These data make me hopeful for the future of melanoma care.”
Navigating a New Path Forward
“After my diagnosis, I was determined to stay the course,” Stoffer explains. “It was scary to know that my plans could be interrupted, but I’ve learned to take everything day-by-day.” Since his diagnosis, Stoffer’s cancer responded to the treatment.
Stoffer is now married to his girlfriend and currently enrolled in medical school. “I feel like a lot was thrown at me: melanoma, medical school and marriage, but I’m grateful that this treatment has allowed me to be here today and to live my life.”
For other patients newly diagnosed with metastatic melanoma, Stoffer emphasizes that finding a doctor and care team that make you feel comfortable and you can be honest with is essential.
Most importantly, Stoffer’s advice to others is to live intentionally and have faith in the process. “Don’t let cancer have the victory it doesn’t deserve. This is your biggest fight for your life – treat it like that.”
To learn more about Opdivo + Yervoy, please click here.
*John Stoffer is a Bristol Myers Squibb Patient Ambassador
OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with a type of skin cancer called melanoma 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.
Important Safety Information for OPDIVO® (nivolumab) and OPDIVO+YERVOY® (ipilimumab)
OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO 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 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.
YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
Serious side effects may include:
● Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
● Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach area (abdomen) pain or tenderness.
● Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; feeling less hungry than usual; and decreased energy.
● Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine.
● Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
● Skin problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes.
● Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck.
● Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; and chest pain.
Additional serious side effects observed during a separate study of YERVOY alone include:
● Nerve problems that can lead to paralysis. Symptoms of nerve problems may include: unusual weakness of legs, arms, or face; and numbness or tingling in hands or feet.
● Eye problems. Symptoms may include: blurry vision, double vision, or other vision problems; and eye pain or redness.
Get medical help immediately if you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may also need to delay or completely stop your treatment.
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
● Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.
● Graft-versus-host disease, a complication that can happen after receiving a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic), may be severe, and can lead to death, if you receive YERVOY either before or after transplant. Your healthcare provider will monitor you for the following signs and symptoms: skin rash, liver inflammation, stomach-area (abdominal) pain, and diarrhea.
Pregnancy and Nursing:
● Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby. If you are a female who is able to become pregnant, your healthcare provider should do a pregnancy test before you start receiving OPDIVO. Females who are able to become pregnant should use an effective method of birth control during treatment and for at least 5 months after the last dose. 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 or think you are pregnant during treatment. You or your healthcare provider should contact Bristol Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
● Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
● Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment and for 5 months after the last dose.
Tell your healthcare provider about:
● Your health problems or concerns if you: have immune system problems such as autoimmune disease, Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions.
● All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of OPDIVO when used alone 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; and stomach-area (abdominal) pain.
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. 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.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.