How are Inlyta and Keytruda used in kidney cancer?

Inlyta and 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. Advanced kidney cancer means the cancer has spread or cannot be removed by surgery.

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

Inlyta and Keytruda 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.

Inlyta 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 Inlyta and Keytruda 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.

Keytruda 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)

Inlyta 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.

Related Questions

• How long does it take for Keytruda to work?
• What are monoclonal antibodies?
• What is the success rate of Keytruda?

How well does Inlyta and Keytruda work in kidney cancer?

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

• Results showed that more patients treated with the combination of Keytruda and Inlyta (86%) lived longer than those receiving sunitinib alone (77%).
• In addition, half of patients receiving Keytruda and Inlyta 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 Keytruda and Inlyta had their tumors shrink (59%) than those receiving sunitinib (36%).

What kind of side effects are common with Inlyta and Keytruda?

Common side effects of Inlyta when given with Keytruda 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 these treatments. 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

• Inlyta (generic name: axitinib) and Keytruda (generic name: 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.
• Inlyta is an oral medication given two times per day and Keytruda is an intravenous (IV) infusion given every 3 weeks or every 6 weeks.
• Inlyta and Keytruda are given for kidney cancer until the disease progresses, 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 Inlyta or Keytruda for safe and effective use and does not replace your doctor's instructions. Review the full product information, and discuss this information with your doctor or other health care provider.