Research Developments in the Treatment of Advanced Kidney Cancer

Renal cell carcinoma (RCC) is the most common type of kidney cancer and is twice as common in men compared to women. This year, it is estimated that RCC will account for more than 12,000 deaths in the United States alone. In some cases, patients are not diagnosed with RCC until the cancer reaches advanced stages, which can make the disease particularly hard to treat. Common signs and symptoms of RCC can include blood in urine, lower back pain on one side, a mass on the side or lower back, loss of appetite or unexplained weight loss.

When John Gibson, a Bristol Myers Squibb patient ambassador, found blood in his urine, he saw a urologist for an examination. What came next turned out to be the biggest challenge of his life: advanced RCC.

Under the direction of his oncologist, Gibson began a clinical trial treatment with a combination of two immunotherapies, Opdivo (nivolumab) plus Yervoy (ipilimumab), which are prescription medications approved by the U.S. Food and Drug Administration to treat advanced RCC in certain people when their cancer has spread. 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.

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 and tissues; severe infusion reactions; and complications of stem cell transplant, including graft-versus-host disease (GVHD), that uses donor stem cells (allogeneic). Call or see your health care provider right away for any new or worsening signs or symptoms. Please see additional Important Safety Information below.

A Chance to Live Longer with Advanced RCC

In a clinical trial of 847 previously untreated patients with kidney cancer that has spread and with one or more risk factors, 425 patients received treatment with the immunotherapy combination of Opdivo + Yervoy, and 422 patients received sunitinib. The clinical trial looked at results such as tumor shrinkage, reduction in risk of death and length of time without tumors worsening.

In the primary analysis at two years, half of the patients on sunitinib were alive at 25.9 months compared to more than half being alive on Opdivo + Yervoy. Opdivo + Yervoy was proven to lower the risk of dying by 37% compared to sunitinib. Patients treated with Opdivo + Yervoy lived 11.6 months without the cancer spreading, growing or getting worse versus 8.4 months with sunitinib; however, there was no meaningful difference between the two treatments.

At the two-year time point, 41.6% of patients treated with Opdivo + Yervoy (95% CI:36.9-46.5) responded to treatment (n=177/425) versus 26.5% (n=112/422) of those treated with sunitinib (95% CI:22.4-31.0). Partial tumor shrinkage occurred in 32.2% of the patients treated with this immunotherapy combination compared to 25.4% of those treated with sunitinib.  Tumors disappeared completely in 9.4% of patients treated with this immunotherapy combination versus in 1.2% of patients treated with sunitinib. The disappearance of any measurable tumors in response to treatment does not necessarily mean the cancer has been cured. Opdivo + Yervoy will not work for everyone. Individual results may vary.

Five-year follow-up data from this trial showed the potential for durable long-term survival in certain patients with advanced RCC. In a follow-up analysis at five years, 43% of patients treated with the immunotherapy combination were still alive versus 31 % treated with sunitinib.

At five years, 42.1% of patients treated with this immunotherapy combination had a response to treatment (n=179/425) versus 26.8% of those treated with sunitinib (n=113/422). In 30.8% of the patients treated, their tumors shrank partially, compared to 24.6% of those treated with sunitinib, and tumors disappeared completely in 11.3% of patients compared to 2.1% of those treated with sunitinib. The disappearance of any measurable tumors in response to treatment does not necessarily mean the cancer has been cured.  

At five years, the most frequent serious adverse reactions reported in >2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. The most common adverse reaction reported in at least 20% of patients treated with the immunotherapy were fatigue, rash, diarrhea, musculoskeletal pain, pruritis, nausea, cough, pyrexia, arthralgia, decreased appetite, dyspnea, and vomiting.

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.

Looking Ahead

Gibson knows the importance of focusing on the road ahead. His tumors started to shrink while on treatment with Opdivo + Yervoy, however, his results may not be typical as it will not work for everyone.

Today, Gibson is grateful for where he is now. To those facing a cancer diagnosis, Gibson recommends “finding a care team that matches your goals, and make sure you follow their instructions along the way.”

To learn more, visit Opdivo.com .

                              
Source: Bristol Myers Squibb

Photo courtesy of Getty Images

INDICATION

OPDIVO® (nivolumab) is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat people with kidney cancer in certain people when their cancer has spread (advanced renal cell carcinoma) and you have not already had treatment for your advanced RCC.

It is not known if OPDIVO is safe and effective in children younger than 18 years of age.

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 health care 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 health care 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 health care team will check you for these problems during treatment and may treat you with corticosteroid or hormone replacement medicines. Your health care 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 health care 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 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 health care provider will monitor you for these complications.

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 health care 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 health care 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 health care 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 health care provider about birth control methods that you can use during this time.
• Tell your health care provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO or YERVOY. You or your health care provider should contact Bristol-Myers Squibb at 1-844-593-7869 as soon as you become aware of a pregnancy.

Tell your health care 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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