New Immunotherapy Combination for Kidney Cancer

This year, kidney cancer will be diagnosed in almost 64,000 people in the United States alone.

Twice as many men as women will be affected. Although the FDA has recently approved many new drugs for the treatment of kidney cancer, death rates have decreased by a mere 1% annually since 2002, highlighting the need for new approaches to treatment.

Renal cell carcinoma (RCC) is the most common form of kidney cancer, representing more than 90% of all cases. Because RCC usually does not cause symptoms during the early stages, this type of cancer can go unnoticed until tumors have grown and spread throughout the body. It is at this late stage that patients begin to experience fatigue, blood in the urine, pain or swelling in the abdomen or flank (the side of the body between the ribs and hip), weight loss, fever, high blood pressure and discomfort. Unfortunately, by the time RCC is diagnosed, tumors are generally too large and widespread to be surgically removed.

I specialize in the treatment of kidney, bladder and prostate cancer. In addition to offering standard treatment options, I continuously strive to bring new therapies to patients who do not respond to, or are not eligible for, standard treatment. One of the newer approaches that I use to treat cancer is immunotherapy.

What is Immunotherapy?

Immunotherapy recruits the body’s own immune system in the fight against cancer. Our immune system is composed of specialized cells that recognize and attack foreign invaders, such as viruses and bacteria, or other threats, like cancer cells. Unfortunately, cancer cells have developed sophisticated ways of evading detection. The goal of immunotherapy is to supercharge the immune system so that it can more effectively recognize, target and eliminate cancer cells.

Roswell Park Clinical Trial Highlights a Promising Drug Combination

As a National Cancer Institute−designated Comprehensive Cancer Center, Roswell Park has access to the latest drugs, including those available only in clinical trials. In 2015, based on the results of one clinical trial, the FDA approved a new immunotherapy drug, nivolumab, for patients with advanced kidney cancer who do not respond to standard treatment. Results of a new clinical trial suggest that combining this immunotherapy drug with a second one, ipilimumab, can be even more effective.

The CheckMate 214 trial enrolled nearly 1,100 patients with advanced or metastatic RCC from 182 locations throughout the world, including Roswell Park. During the study, half of the patients received combination immunotherapy, while the other half received standard treatment with sunitinib, a targeted drug commonly used to treat advanced RCC.

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Remarkably, we found that when used together, nivolumab and ipilimumab reduced the risk of death by 32% in the entire study population and by an even more impressive 37% in a group of patients whose initial outlook was unfavorable. In other words, RCC patients who received immunotherapy tended to respond better and survive longer than those who received standard treatment.

Nivolumab and ipilimumab are in a class of drugs known as immune checkpoint inhibitors. Checkpoints are molecules on immune cells that can be turned on or off to either start or stop an immune response. This feature is very useful when trying to prevent attacks on healthy, normal cells, but cancer cells have developed ways to interfere with these checkpoints. The drugs both target T cells, an essential type of white blood cell that acts as a first responder, recognizing and attacking threats like viruses, bacteria or even cancer. Nivolumab blocks a particular protein on T cells called PD-1, and ipilimumab blocks a molecule known as CTLA-4. By inhibiting these checkpoints, each drug boosts the body’s natural immune response against cancer.

This immunotherapy combination achieved “breakthrough therapy” status in the recent past, and we hope that our new results will encourage the FDA to grant full approval for this promising combination, which will change the standard of care for RCC in the near future. Our findings were reported at the 2017 annual meeting of the European Society for Medical Oncology in Madrid and the 2017 International Kidney Symposium in Miami, and they have just been published in The New England Journal of Medicine.

UPDATE: Since the original trial in 2018, the study is continuing to confirm the early findings. The combination used in Checkmate 214 is still effective in treating patients with advanced renal cell carcinoma and survival rate of the patients originally enrolled is 60%. In 2019, the FDA approved two new combinations of drugs that are being used to right kidney cancer: axitinib and pembrolizumab, and a combination of axinitib and avelumab.