Numbers touch nearly every aspect of our life, from social security number assigned at birth, to the ever-growing list of passwords, addresses, telephone numbers and miles traveled. You never know at what point one previously insignificant number might suddenly become fundamental.
Take 14 and 25. Alone, these numbers could mean nothing, anything. But to some, they are a statistic that needs to be changed. Because currently in the U.S., 14 percent of all new cancers are lung cancers, and 25 percent of all cancer deaths are attributed to this disease. Lung cancer causes more deaths than breast, colon and prostate cancers combined. Non-small cell lung cancer (NSCLC) represents 80-85 percent of all lung cancers, and is often diagnosed in its later stages, once it’s spread and become more serious. This diagnosis can be distressing, as patients may have little knowledge of treatment options or what to expect now that life has taken this unexpected turn.
Chemotherapy, surgery and radiation have long represented the standard of care; however, advanced lung cancer’s aggressive nature is driving doctors and scientists to find ways to understand and treat it in new ways. This includes immunotherapies, which work differently, and are now often included among the traditional standard of care options like chemotherapy, surgery and radiation for certain types of cancer patients.
“Research is pushing the boundaries of what we know about the immune system’s ability to fight cancer, which is very exciting,” said David Spigel, MD, Chief Scientific Officer; Director, Lung Cancer Research Program; Principal Investigator, Sarah Cannon, Nashville, Tennessee.
There are several types of immunotherapies approved to treat lung cancer. Up to about half of patients with NSCLC develop recurrence, which means a second line of treatment is needed. Bristol-Myers Squibb’s Opdivo® (nivolumab) is an immunotherapy approved for several uses, including 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. It also may be used in patients whose tumor has an abnormal EGFR or ALK gene, if they have first tried an FDA-approved therapy that did not work or is no longer working. It is not known if Opdivo is safe and effective in children less 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.
Opdivo was the first and only immunotherapy to demonstrate a survival advantage in two different phase 3 clinical trials for adults with advanced NSCLC who had previously received chemotherapy. These trials included patients with non-squamous and squamous lung cancer.
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). Opdivo reduced the risk of dying by 27 percent compared to the chemotherapy. Half of the patients on Opdivo were alive at 12.2 months, compared to 9.4 months with chemotherapy. Opdivo was shown to partially or completely shrink tumors in 19 percent of patients (56 out of 292), compared to 12 percent with chemotherapy (36 out of 290 patients), and there was no difference between the treatments in the length of time that patients lived without their tumors worsening.
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 platinum-based chemotherapy, 135 received Opdivo and 137 chemotherapy (docetaxel). Opdivo reduced the risk of dying by 41 percent compared to chemotherapy. Half of the patients on Opdivo were alive at 9.2 months, compared to six months with chemotherapy. Opdivo was shown to partially or completely shrink tumors in 20 percent of patients (27 out of 135), compared to 9 percent with chemotherapy (12 out of 137 patients). The length of time that half of the patients lived without their tumors worsening was 3.5 months with Opdivo and 2.8 months for chemotherapy.
The most common side effects of Opdivo when used alone include: feeling tired; pain in muscles, bones, and joints; diarrhea; cough; constipation; back pain; fever; rash; itchy skin; nausea; shortness of breath; decreased appetite; upper respiratory tract infection; and weakness. Please see additional important safety information below.
In the patients for which Opdivo is approved, the treatment has now been studied for more than two years. In a follow up to the main analysis of the trial in previously treated advanced non-squamous NSCLC, overall survival (OS) rates, meaning the length of time from diagnosis or treatment initiation that patients remain alive, for Opdivo at two years were 29 percent (81 out of 292 patients), versus 16 percent of those treated with chemotherapy (docetaxel) (45 out of 290 patients). For patients with previously treated advanced squamous NSCLC, data from a follow up to the main analysis show that 23 percent were alive at two years (29 out of 135 patients) versus 8 percent of those treated with chemotherapy (11 out of 137 patients). The safety profile of Opdivo at two years was similar to previous reports from both studies.
“These data points are very important to patients battling this disease. Until recently we wouldn’t have imagined we’d be sharing two-year data,” said Dr. Spigel. “Now that we are starting to see some patients survive, we have some additional aspects to focus on – how do we better determine which patients respond to treatment and how do we increase survival? That’s the goal, and we will continue to uncover new ways of treating this disease and training our bodies to fight back.”
Healthcare professionals, researchers, advocates, caregivers and patients all bring unique expertise to those impacted by cancer, and, as with everything in science, these insights have exponential value when they collaboratively work to bring their ideas together.
For those fighting this type of cancer, start a conversation today with your doctor. Ask whether Opdivo may be right for you or your loved one.
To learn more about Opdivo, visit www.opdivo.com.
OPDIVO® (injection for intravenous use 10 mg/mL) is a prescription medicine used to treat 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 less than 18 years of age.
Important Safety Information for OPDIVO® (nivolumab)
OPDIVO is a medicine that may treat your, lung cancer by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in many areas 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; and feeling less hungry than usual.
- 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; and severe muscle weakness.
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; pain in muscles, bones, and joints; diarrhea; cough; constipation; back pain; fever; rash; itchy skin; nausea; shortness of breath; decreased appetite; upper respiratory tract infection; and weakness.
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. You may also report side effects to Bristol-Myers Squibb at 1-800-721-5072.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO. (BPT)
3. DeVita V, Rosenberg S. Two Hundred Years of Cancer Research. New England Journal of Medicine. 2012;366(23):2211. doi:10.1056/nejmra1204479.
7. Carnio S, Novello S, Papotti M, Loiacono M, Scagliotti GV. Prognostic and predictive biomarkers in early stage non-small cell lung cancer: tumor based approaches including gene signatures. Translational Lung Cancer Research. 2013;2(5):372-381. doi:10.3978/j.issn.2218-6751.2013.10.05.
8. Kazandjian D, Suzman DL, Blumenthal G, et al. FDA Approval Summary: Nivolumab for the Treatment of Metastatic Non-Small Cell Lung Cancer With Progression On or After Platinum-Based Chemotherapy. The Oncologist. 2016;21(5):634-642. doi:10.1634/theoncologist.2015-0507.
9. Driscoll JJ, et al. Overall survival: still the gold standard: why overall survival remains the definitive end point in cancer clinical trials. Cancer J. 2009; 15(5):401-5.
11. Borghaei H et al. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. The New England Journal of Medicine. October 2015:1627-1639.
12. Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non–Small-Cell Lung Cancer. The New England Journal of Medicine. 2015;373(2):123-135. doi:10.1056/NEJMoa1504627.
13. Borghaei H et al. Presented at the American Society of Clinical Oncology 2016 Annual Meeting; June 3-7, 2016; Chicago, IL, USA. Poster 9025.