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How are axitinib and pembrolizumab used in kidney cancer?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Nov 11, 2020.

Official Answer

by Drugs.com

Axitinib and pembrolizumab were approved by the FDA in April 2019 as a combination therapy for first-line treatment of kidney cancer (advanced renal cell carcinoma or RCC) in adults. Advanced kidney cancer means the cancer has spread or cannot be removed by surgery.

  • Axitinib (brand name: Inlyta) is an oral medication given two times per day.
  • Pembrolizumab (brand name: Keytruda) is given as an intravenous (IV) infusion every 3 weeks or every 6 weeks. Pembrolizumab is usually given in an outpatient clinic and infusions typically takes at least 30 minutes.

Axitinib and pembrolizumab are given until the kidney cancer has progressed, there are unacceptable side effects, or for Keytruda, up to a period of 24 months. Your doctor will decide how many treatments you need.

Axitinib is also approved:

  • to be used alone to treat RCC as a second line drug after the failure of one previous medication
  • in combination with avelumab (brand name: Bavencio), for the first-line treatment of patients with advanced RCC.

What is advanced renal cell carcinoma?

You have two kidneys, which are bean-shaped organs located on either side of the backbone in the mid-back area. Kidney cancer starts when normal cells in the kidney change into abnormal cells. These abnormal cells then grow out of control and may spread.

The kidneys have several important functions:

  • to filter blood and remove excess salt, water, and waste products through urine
  • to help control blood pressure by making a hormone called renin
  • to help control the number of red blood cells by making a hormone called erythropoietin

There are several types of kidney cancer, but renal cell carcinoma (RCC) is the most common type. About 90% of kidney cancers (90 of every 100) are RCC.

People can live a normal, healthy life with only one kidney.

Why are axitinib and pembrolizumab combined?

  • In general, traditional chemotherapy is not very effective against advanced kidney cancer.
  • Combining drugs with different mechanisms of action, like immunotherapy and targeted treatments, has shown greater success.
  • These options are now often used as initial (first-line) treatments for advanced kidney cancer.

Pembrolizumab is a type of immunotherapy drug called an Immune Checkpoint Inhibitor. It binds to the PD-1 receptor on the T-cell to help block cancer cells from linking to and inactivating the cancer-fighting T-cells (an anti-PD-1 therapy)

Axitinib is considered a targeted treatment, not an immunotherapy drug. It is a tyrosine kinase inhibitor and vascular endothelial growth factor receptor inhibitor (VEGF/VEGFR inhibitor). It blocks cell proteins and signals directed at blood vessels to help slow down the growth of new blood vessels that fuel the spread of cancer growth.

Renal cell carcinoma is a type of kidney cancer where programmed death ligand-1 (PD-L1) expression may contribute to cancer growth and vascular endothelial growth factor (VEGF) plays a key role in growth of blood vessels that supply the tumor.

How well does axitinib and pembrolizumab work in kidney cancer?

In a clinical trial with 861 patients with advanced renal cell carcinoma, the combination of pembrolizumab and axitinib was compared with sunitinib (Sutent) given alone, another tyrosine kinase inhibitor. Statistically significant results were shown in favor of pembrolizumab and axitinib for several clinical outcomes.

  • Results showed that more patients treated with the combination of pembrolizumab and axitinib (86%) lived longer than those receiving sunitinib alone (77%).
  • In addition, half of patients receiving pembrolizumab and axitinib were still living without their cancer spreading, growing, or getting worse at 15 months. For patients receiving sunitinib alone, half were alive at 11 months.
  • The combination reduced the risk of the cancer growing, spreading or worsening by 31% when compared to sunitinib.
  • More patients receiving pembrolizumab and axitinib had their tumors shrink (59%) than those receiving sunitinib (36%).

What kind of side effects are common with axitinib and pembrolizumab?

Common side effects of axitinib when given with pembrolizumab include:

  • diarrhea
  • fatigue
  • weakness
  • high blood pressure
  • liver problems
  • low levels of thyroid hormone
  • decreased appetite
  • blisters or rash on the palms of your hands and soles of your feet
  • nausea
  • mouth sores or swelling of the lining of the mouth, nose, eyes, throat, intestines, or vagina
  • hoarseness
  • rash
  • cough
  • constipation

These are not all the side effects that may occur with axitinib and pembrolizumab treatment. More serious side effects, such as infusion reactions and autoimmune reactions can occur. Review the side effects in more detail and talk to your doctor about what you can expect with this treatment.

Bottom Line

  • Axitinib (brand name: Inlyta) and pembrolizumab (brand name: Keytruda) were approved by the FDA in April 2019 as a combination therapy for first-line treatment of kidney cancer (advanced renal cell carcinoma or RCC) in adults.
  • Axitinib is an oral medication given two times per day and pembrolizumab is an intravenous (IV) infusion given every 3 weeks or every 6 weeks.
  • Axitinib and pembrolizumab are given until disease progression, there are unacceptable side effects, or for Keytruda, up to a period of 24 months. Your doctor will decide how many treatments you need.

This is not all the information you need to know about axitinib (Inlyta) or pembrolizumab (Keytruda) for safe and effective use. Review the full product information, and discuss this information with your doctor or other health care provider.

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