Sponsored by Bristol Myers Squibb: An Advanced Melanoma Diagnosis Didn’t Stop One College Student from Pursuing his Dreams of Medical School

"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 can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; eye problems; problems in other organs or tissues; severe infusion reactions; and complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call your healthcare provider right away for any new or worsening signs or symptoms. 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

INDICATIONS

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)

What is the most important information I should know about OPDIVO + YERVOY?
OPDIVO and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO and YERVOY 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 life-threatening and 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. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.

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 heart beat; 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

Eye problems: blurry vision, double vision, or other vision problems; eye pain or redness.

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 OPDIVO and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
● Chest pain; irregular heartbeat; shortness of breath; swelling of ankles
● 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 eye sight
● 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 and may treat you with corticosteroid or hormone replacement medicines. Your healthcare team may also need to delay or completely stop your treatment if you have severe side effects.

Possible side effects of OPDIVO + YERVOY

OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:

●See “What is the most important information I should know about OPDIVO + YERVOY?”
Severe infusion reactions. Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; and feel like passing out; fever; back or neck pain.
Complications, including graft-versus-host disease (GVHD), of bone marrow (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 OPDIVO or YERVOY. Your healthcare provider will monitor you for these complications.

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. You are encouraged to report side effects of prescription drugs to the FDA. Call 1-800-FDA-1088.

Before receiving OPDIVO or YERVOY , tell your healthcare provider about all of your medical conditions, including 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 received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO
● have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
● are pregnant or plan to become pregnant. OPDIVO and YERVOY can harm your unborn baby.
● are breastfeeding or plan to breastfeed. It is not known if OPDIVO or YERVOY passes into your breast milk. Do not breastfeed during treatment with OPDIVO or YERVOY and for 5 months after the last dose of OPDIVO or YERVOY.

Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start receiving OPDIVO or YERVOY.
● You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of OPDIVO or YERVOY . 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 may be pregnant during treatment with OPDIVO or YERVOY. You or your healthcare provider should contact Bristol-Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.
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 OPDIVO and YERVOY.

© 2020 Bristol-Myers Squibb Company. All Rights Reserved.

OPDIVO® and YERVOY® are registered trademarks of Bristol-Myers Squibb Company.

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