A closer look at lung cancer

As the nation once again pauses to commemorate the journeys of patients and their loved ones during Lung Cancer Awareness Month (LCAM), November also represents a moment of celebration. It is a time to share stories of survival, recognize progress achieved by advocates in the lung cancer community and observe promising trends in cancer research.

The face of cancer is changing in America.

As of 2016 there were an estimated 15.5 million cancer survivors in the United States, and from 1991 to 2015, the overall cancer death rate dropped 26 percent. Some reasons for today’s improved cancer survival rates include the availability of screening tests that can help find cancers earlier, better therapies and improved treatment side effect management. Broadly, the number of cancer survivors is only anticipated to grow, with an estimated 20.3 million expected in the ranks by 2026.

With the trend of growing cancer survivorship, the lung community is rallying behind initiatives that address new ways to tackle more difficult-to-treat cancers. Advanced-stage non-small cell lung cancer (NSCLC) is one such disease where lower survival rates have encouraged further research into treatment options.

“Overall survival — defined as the length of time from either the date of diagnosis or the start of treatment, that patients remain alive — is considered one of the most important goals for cancer treatment. Though survival rates are still relatively low, we’re just recently starting to see improvements in lung cancer, which can be quite difficult to treat, particularly in patients who have already tried one or more therapies. That fact is very encouraging,” said Eric Whitman, M.D., FACS, medical director, Atlantic Health System Cancer Care.

Clinical data offers hope.

One of the treatments that may help to improve overall survival (OS) for some patients with NSCLC is Bristol-Myers Squibb’s Immuno-Oncology therapy. Opdivo^® (nivolumab) harnesses the body’s own immune system to fight cancer, which offers some patients the potential for a longer life. In some cases, Opdivo can cause a patient’s T cells to attack healthy cells contained within organs and tissues in any area of the body and can affect the way they work. As Immuno-Oncology research evolves, it is opening the door to the identification of more personalized treatment approaches.

“What’s really exciting is that it’s still early in the evolution of this therapy. We’re constantly driven to further understand its impact, as well as which patient type is most likely to benefit, with the goal of being able to individualize treatment as much as possible,” said Awny Farajallah, M.D., head of U.S. Medical at Bristol-Myers Squibb.

Opdivo is approved for adults with advanced NSCLC that has spread or grown and if platinum-based chemotherapy (a common treatment) did not work or is no longer working. If patients’ tumors have an abnormal EGFR or ALK gene, they should have also tried a U.S. Food and Drug Administration (FDA)-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working. It is not known if Opdivo is safe and effective in children younger than 18 years of age. Opdivo will not work for every patient, and results may vary.

Opdivo can cause problems that can sometimes become serious or life-threatening and can lead to death. 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. Please see additional Important Safety Information below.

In patients with advanced NSCLC who had received prior treatment, Opdivo has been studied for three years. In the main analysis of a clinical trial looking at 582 patients whose advanced non-squamous NSCLC had spread or grown after treatment with a platinum-based chemotherapy, 292 were treated with Opdivo and 290 with chemotherapy (docetaxel).

In the main analysis of a separate trial looking at 272 patients whose advanced squamous NSCLC (another type of lung cancer) spread or grew after treatment with a platinum-based chemotherapy, 135 received Opdivo and 137 received chemotherapy (docetaxel).

The most common side effects of Opdivo when used alone include: feeling tired; pain in muscles, bones, and joints; diarrhea; weakness; shortness of breath; decreased appetite; upper respiratory tract infection; headache; rash; itchy skin; nausea; cough; constipation; back pain; fever; and stomach pain. Please see additional Important Safety Information below.

“The progress we have achieved at Bristol-Myers Squibb over the past few years would not have been possible without the patients and health care providers who have contributed to clinical trials, and we cannot thank them enough,” said Dr. Farajallah. “We continually look to build on this experience to help improve patient care.”

What’s next?

The increasing number of people living with cancer will likely pose potential new challenges for the community.

“After diagnosis, people are now faced with the question of, ‘How do I live with cancer?’ beyond just getting through treatments,” Dr. Whitman continued. “It’s important not to overlook the other needs of these patients.”

As those with cancer move along in their treatment journeys, they may face a new set of obstacles. Relationships with family members and friends, as well as interactions with health care professionals, may change. The idea of potentially going back to work could feel overwhelming.

Experts recommend cancer patients maintain open communication with their health care teams, use available care resources and seek support from loved ones and the cancer community when needed.

Awareness months like LCAM are important opportunities for those impacted by lung cancer to come together to connect and share stories of hope, and for the broader community to rally behind patients, building enough momentum to support those impacted by lung cancer all year long.

“We obviously don’t know what the future holds, but the landscape of this disease and its treatment are evolving in an encouraging way. That can offer hope for the millions of patients touched by cancer,” said Dr. Whitman.

To learn more about Opdivo and its other indications, visit Opdivo.com .

Please see Important Safety Information for Opdivo below. Please see U.S. Full Prescribing Information and Medication Guide for Opdivo.

INDICATION

OPDIVO® (nivolumab) is a prescription medicine used to treat people with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread or grown and you have tried chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

Important Safety Information for OPDIVO® (nivolumab)

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.

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.

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment, if you have severe side effects.

OPDIVO can cause serious side effects, including:

• Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.

Pregnancy and Nursing:

Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. 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. Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment.

Tell your healthcare provider about:

• Your health problems or concerns if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; 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; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; and abdominal pain.

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.

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

Opdivo® is a trademark of Bristol-Myers Squibb Company. © 2018 Bristol-Myers Squibb Company. All Rights Reserved. 1506US1803428-01-01

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