Colorectal Cancer on the Rise: Understand Treatment Options
(BPT) - This sponsored article is presented by Bristol Myers Squibb
Colorectal cancer (CRC) is emerging as a critical health concern, particularly due to a concerning rise in diagnoses among younger individuals. Colorectal cancer (CRC), developing in the colon or rectum, is projected to impact more than 154,000 Americans in 2025, making it the third most diagnosed form of cancer. Particularly troubling trends show an increasing incidence in individuals younger than 50, alongside rising mortality rates in those under 55 since the mid-2000s. These trends underscore an urgent and growing need for enhanced awareness, early detection and effective treatment options.
Fortunately, continued scientific research is opening additional options for treatment. For certain patients, treatment with immunotherapy, which harnesses the body's own immune system to help fight disease, may offer a promising path forward. Some patients may be eligible to receive dual immunotherapy, combining two immunotherapy treatments that can help attack cancer cells by targeting different immune checkpoints.
One such dual immunotherapy treatment is Opdivo® (nivolumab) plus Yervoy® (ipilimumab). This combination is approved by the U.S. Food and Drug Administration to treat adults and children 12 years of age and older with a specific type of colorectal cancer that cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). MSI-H and dMMR are biomarkers, which indicate the status of DNA stability in a tumor, and occur in approximately 15% of CRC tumors. Of the 15%, 4-5% of tumors are metastatic. Biomarker testing is strongly recommended for anyone with CRC and can help determine appropriate treatment options.
"Opdivo plus Yervoy is the first FDA-approved combination of two immunotherapies, representing a distinct approach different from chemotherapy," said Heinz-Josef Lenz, MD, CheckMate-8HW investigator and Deputy Director for Research Programs and Head of the Gastrointestinal Cancers Program at the USC Norris Comprehensive Cancer Center.* "When these immunotherapies are used in combination, these treatments work with your immune system to allow your immune cells to help fight the cancer. This immune response may be greater when both immune therapies are combined than when either is used alone."
It's also important to understand that while doing so, this immunotherapy combination 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 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.
Serious side effects may include lung problems; intestinal problems; liver problems; hormone gland problems; kidney problems; skin problems; eye problems; problems in other organs and issues; and complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (or allogeneic). Call or see your healthcare provider right away for any new or worsening signs or symptoms. Opdivo is associated with severe infusion reactions. Please see additional Important Safety Information below.
Opdivo plus Yervoy is an FDA-approved combination of two immunotherapies that has demonstrated benefit for certain patients with advanced CRC. In the CheckMate-8HW trial, this combination helped patients live significantly longer without their cancer progressing compared to certain other treatment groups in the clinical trial.
The clinical trial included 839 people with advanced MSI-H/dMMR colorectal cancer, and compared Opdivo plus Yervoy to either Opdivo alone or investigator's choice of certain chemotherapies with or without targeted therapy. People who received Opdivo plus Yervoy lived significantly longer without their cancer spreading, growing, or worsening compared to those on investigator's choice of chemotherapy. At an approximately 2.5 year follow-up, more than half the people went without their cancer spreading, growing, or getting worse in the Opdivo plus Yervoy group, compared to the investigator's choice of chemotherapy group where at 6 months, half of the people went without their cancer spreading, growing, or getting worse. This translated to a 79% lower risk of cancer progression for the Opdivoplus Yervoygroup compared to chemotherapy. Furthermore, against Opdivoalone, patients treated with Opdivoplus Yervoylived significantly longer without disease progression. At an approximately 4 year follow-up, more than half the people went without their cancer spreading, growing, or getting worse. This translated to a 38% lower risk of cancer progression compared to the Opdivo alone group, where at approximately 40 months, half of the people went without their cancer spreading, growing, or getting worse.
"With the CRC cases unfortunately rising, especially among younger populations, understanding treatment options available for advanced-stage MSI-H/dMMR CRC is more important than ever," said Heinz-Josef Lenz, MD. "If you or a loved one is facing a diagnosis with advanced CRC, I encourage you to have an open conversation with your healthcare team about biomarker testing to find out if Opdivoplus Yervoycould be a treatment option for you."
To learn more about Opdivo + Yervoy, please visit Opdivo.com.
*Dr. Lenz was contracted with Bristol Myers Squibb for this article but did not receive any compensation for sharing his perspective for this story.
Indications
OPDIVO® (nivolumab) is a prescription medicine that may be used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
OPDIVO® (nivolumab) is a prescription medicine that may be used alone to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.
Important Safety Information for OPDIVO® (nivolumab) + 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 another therapy.
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:
- Lung problems: 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; swollen lymph nodes; painful sores or ulcers in the mouth or nose, throat, or genital area; fever or flu-like symptoms
- 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 eyesight
- Persistent or severe muscle pain or weakness; muscle cramps
- Low red blood cells; bruising
Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ transplant that you have had.
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; 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 serious 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; itching; diarrhea; nausea; weakness; cough; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; stomach-area (abdominal) pain; vomiting; and urinary tract infection.
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); constipation; decreased weight; and dizziness.
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, including corneal 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 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.
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.
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OPDIVO®, YERVOY® and the related logos are registered trademarks of Bristol-Myers Squibb Company
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