FDA Approvals, News & UpdatesLung Cancer

Immunotherapy Combination Provides New Hope for Patients with Certain Type of Non–Small-Cell Lung Cancer

A treatment combination containing the immunotherapy drugs Opdivo (nivolumab) and Yervoy (ipilimumab) received 2 approvals in non–small-cell lung cancer (NSCLC) in the past year.
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A treatment combination containing the immunotherapy drugs Opdivo (nivolumab) and Yervoy (ipilimumab) received 2 approvals in non–small-cell lung cancer (NSCLC) in the past year. First, the drug combination was approved for the first-line treatment of metastatic NSCLC expressing PD-L1 as determined by an FDA-approved test, and no EGFR or ALK genomic tumor aberrations. Days later, the combination was approved, when given with 2 cycles of chemotherapy, for the first-line treatment of patients with advanced-stage NSCLC and whose tumors do not have an abnormal EGFR or ALK gene. These treatments provide new hope for patients with this type of lung cancer and can be used in people who have not yet received treatment for their cancer (first-line treatment), whose lung cancer has spread to other parts of their body (metastatic) or has come back (recurrent). Your doctor will conduct gene testing on the tumor tissue from your lung cancer to determine whether your tumor has an abnormal EGFR or ALK gene, because this particular treatment should not be used on people whose tumors carry mutations in those genes.

What Is Immunotherapy?

Immunotherapy is a type of cancer treatment that “teaches” the body’s own immune system to recognize and fight cancer cells. However, it can also cause the immune system to attack normal organs and tissues in other parts of the body. When this happens, a whole host of side effects can occur; these side effects are called immune- mediated adverse reactions (or immune-mediated side effects).

These problems may happen anytime during treatment with immunotherapy, or weeks or months after treatment has ended. It is important for patients to know how to recognize these side effects (and to know that more than 1 of these side effects may occur at the same time), because they can be serious and can even lead to death. Additionally, when immunotherapies are combined, like in the case of Opdivo and Yervoy, these types of side effects may occur more often. However, the earlier they are caught, the more easily they are treated.

During treatment, your healthcare team will check you for side effects and may treat you with steroids or hormone replacement medicines. If side effects are severe enough, your doctor might decide to delay or completely stop your treatment.

What Are the Side Effects?

The most common side effects of Opdivo and Yervoy are feeling tired; pain in the muscles, bones, and joints; nausea; diarrhea; rash; decreased appetite; constipation; and itching.

However, serious side effects (ones that can be life-threatening or deadly) tend to fall into certain categories, like lung problems, intestinal problems, liver problems, hormone gland problems, kidney problems, skin problems, and eye problems. Most of these symptoms are caused by inflammation and can be managed. However, it is extremely important that you call or visit your doctor right away if you develop any new or worse signs or symptoms related to these serious side effects.

Lung problems to watch out for include new or worsening cough, shortness of breath, and chest pain. Intestinal problems may show up in the form of diarrhea or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach pain or tenderness.

Liver problems are typically characterized by yellowing of the skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area, dark urine (tea-colored), or bleeding or bruising more easily than normal.

Hormone problems can rear their head in a wide variety of ways and may include headaches that will not go away, sensitivity to light, eye/vision problems, rapid heartbeat, increased sweating, extreme tiredness, constipation, or feeling cold. Kidney problems may show up as blood in your urine, a decrease in your amount of urine, swelling in your ankles, or loss of appetite.

Finally, skin problems to look out for include rash, itching, skin blistering/peeling or painful sores or ulcers in the mouth, nose, throat, or genital area, while eye problems include blurry vision, double vision, or eye pain or redness.

It is important to know that these are not all of the immune system problems that can occur on this drug combo, so call your doctor right away if you have any symptoms that are concerning to you, like confusion, memory problems, tingling or numbness of the arms or legs, or muscle cramps.

Opdivo and Yervoy are given via intravenous (IV) injection, and patients may also experience allergic reactions to the IV infusion (characterized by symptoms like chills, shaking, itching, or rash). Tell your healthcare provider if you experience any of these symptoms during an infusion.

Tell Your Doctor If…

This drug combo can cause harm to an unborn baby and can lead to a miscarriage, so women who are pregnant or plan to become pregnant should not take this drug combination, and women who can become pregnant should take effective birth control during treatment and for at least 5 months after the last dose. It is unknown if these immunotherapy drugs pass into the milk of a breastfeeding woman, so patients should not breastfeed while receiving this treatment.

Before taking the Opdivo/Yervoy combination, patients should tell their doctor about any medical conditions, including any immune system problems (like Crohn’s disease, ulcerative colitis, or lupus); if they have had an organ transplant or if they have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic); if they have received radiation treatment to the chest area in the past, or if they have a previously diagnosed condition that affects the nervous system (like myasthenia gravis or Guillain-Barré syndrome).

Patients should also tell their healthcare provider about any prescription and over-the-counter medicines they take, including vitamins and herbal supplements.

When receiving Opdivo and Yervoy in combination with chemotherapy, patients should always keep in mind that getting medical treatment right away for treatment-related side effects may keep them from becoming more serious. In addition to getting checked regularly by their doctor, patients should continuously monitor their own side effects, and when in doubt, should call their care team with any and all concerns.

Sarlis Says

The approval of Opdivo plus Yervoy has broadened the frontline therapeutic options for patients with non–small-cell lung cancer (NSCLC). For patients with metastatic or recurrent NSCLC, without targetable tumor genomic aberrations in EGFR or ALK, this firstline combination immunotherapy, which may be offered with 2 cycles of platinum doublet chemotherapy, shows significant overall survival and progression-free survival benefits over standard chemotherapy.

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Last modified: February 11, 2021

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