Use of Immunotherapeutic Expanded to Kidney Cancer

The U.S. Food and Drug Administration approval provides a new option for patients with the most common type of kidney cancer

Use of the immunotherapeutic nivolumab (Opdivo) was recently expanded by the U.S. Food and Drug Administration (FDA) to include certain patients with kidney cancer.

Nivolumab is intended for patients with advanced renal cell carcinoma – the most common form of kidney cancer diagnosed in U.S. adults – whose disease has progressed despite treatment with at least one antiangiogenic therapeutic, a form of treatment that prevents tumors from establishing the blood and lymphatic vessel networks they need to grow and survive. The immunotherapeutic was shown to extend overall survival for patients in a randomized phase III clinical trial.

Kidney cancer is among the 10 most commonly diagnosed cancers in the United States. In fact, the National Cancer Institute estimates that there will be 61,560 new cases of kidney and renal pelvis cancer diagnosed in the United States this year alone. Patients with advanced kidney and renal pelvis cancer have a particularly poor prognosis – the five-year relative survival rate for this form of the disease is just 11.8 percent.

The approval of nivolumab for advanced renal cell carcinoma was based on results from the CheckMate 025 phase III clinical trial, which were published in The New England Journal of Medicine. In short, nivolumab extended overall survival for patients with renal cell carcinoma that had progressed despite treatment with one or more antiangiogenic therapeutics (for example, sorafenib [Nexavar] or sunitinib [Sutent]) compared with everolimus (Afinitor), which is a recommended treatment in this situation. Specifically, overall survival was 25 months for those who received nivolumab compared with 19.6 months for those who received everolimus.

Nivolumab works by releasing the PD-1/PD-L1 brake on cancer-fighting immune cells called T cells. As a result, during its development, researchers hoped that nivolumab’s anticancer effects would not be limited to a single type of cancer. This is proving to be the case, and this FDA approval expands the list of cancer types for which nivolumab is an approved treatment to three. It was first approved in December 2014, for treating certain patients with advanced melanoma, and earlier in 2015, nivolumab was approved for both the squamous and nonsquamous forms of non–small cell lung cancer. With promising early results reported from a number of clinical trials testing nivolumab as a potential treatment for other types of cancer, including Hodgkin lymphoma and hepatocellular carcinoma, we may see more FDA approvals for this immunotherapeutic in the near future.

This article was adapted with permission from a post on the AACR's official blog, CANCER RESEARCH Catalyst. The FDA approval was rendered on Nov. 23, 2015. Find out more about the decision on the FDA website.

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