FDA Approves Opdivo and Yervoy As First Combined Immunotherapy for NSCLC

The United States Food and Drug Administration (US FDA) has approved the use of Opdivo (nivolumab) and Yervoy (ipilimumab) together for non-small cell lung cancer (NSCLC). Opdivo (nivolumab) and Yervoy (ipilimumab) are immunotherapy drugs that target different steps in the body’s immune system. It is the first combination immunotherapy approved for the treatment of NSCLC. This is an exciting approval, as it potentially gives people with limited options a new treatment opportunity. No previous cancer treatments are required before trying this new combination. It can be used as a first-line option.

Talk to your doctor about biomarker testing

Specifically, the combination of nivolumab and ipilimumab is for people with NSCLC that has spread to other parts of their body (metastatic NSCLC). People using the combination of these drugs must also have tumor cells that have a specific protein called PD-L1. Further, these tumor cells cannot have mutations in genes called EGFR or ALK.

Your doctor can run a genetic test to determine if the combination of nivolumab and ipilimumab is appropriate in your situation. A new genetic test designed specifically for this purpose was also approved by the FDA.

How do nivolumab and ipilimumab work?

Nivolumab and ipilimumab block different steps in the way cells communicate with one another. Nivolumab blocks a protein on the outside of cells called PD-1 (programmed death receptor-1). Ipilimumab blocks a protein called CTLA-4 (human cytotoxic T-lymphocyte antigen 4). Both drugs play a role in improving the body’s natural cancer-fighting abilities. By helping cancer-fighting cells better do their job, tumors may get smaller and the spread of a person’s cancer may be slowed.

Nivolumab and ipilimumab in clinical trials

The combination of nivolumab and ipilimumab was studied in the CHECKMATE-227 clinical trial. About half of participants were given the new combination of drugs, while the other half were given standard chemotherapy.

The overall survival for those taking nivolumab and ipilimumab was longer than those taking chemotherapy alone (17.1 months compared to 14.9 months). The length of response was also longer for those taking nivolumab and ipilimumab compared to standard chemotherapy (23.2 months versus 6.2 months). These results suggest that people taking the combination of nivolumab and ipilimumab may respond to the treatment for longer than chemotherapy. The new combination may also extend survival.

What are the side effects of nivolumab and ipilimumab?

When taken together, the most common side effects of nivolumab and ipilimumab include:

  • Fatigue
  • Diarrhea
  • Nausea, vomiting, or decreased appetite
  • Decreased weight
  • Rash or itching
  • Fever
  • Muscle and/or joint pain
  • Abdominal pain
  • Cough and/or shortness of breath
  • Headache and/or dizziness
  • Upper respiratory tract infections
  • Low thyroid function (hypothyroidism)

This is not a full list of all potential side effects. Your doctor can provide you with more information on taking nivolumab and ipilimumab together.

Things to know about nivolumab and ipilimumab

As with other drugs, there are rare but serious side effects that can occur when taking nivolumab and ipilimumab together. These two drugs can both impact the immune system and cause inflammation or damage to many organs. This includes the lungs, gastrointestinal tract, liver, hormone-making glands, kidneys, brain, and skin. Your doctor will monitor you closely for signs of any of these reactions.

Both drugs are given as an infusion into the veins (IV). Reactions can occur at the site of infusion. The rate the drug is administered can be slowed down in order to prevent or reduce infusion site reactions.

Nivolumab and ipilimumab may harm an unborn baby and could potentially pass through breast milk. Because of this, effective birth control methods are needed for both men and women taking these drugs. Additionally, women taking nivolumab and ipilimumab are advised not to breastfeed.

Approval expansion update

On May 26, 2020, the FDA approved the combination of nivolumab and ipilimumab with 2 cycles of platinum-doublet chemotherapy as a first-line treatment for those with NSCLC without EGFR or ALK tumor mutations.4

Read the prescribing information to learn more about Opdivo (nivolumab) and Yervoy (ipilimumab).1-3

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