Nivolumab, an immune checkpoint inhibitor, improves survival among patients with advanced renal cell carcinoma, a new study published online ahead of print in The New England Journal of Medicine and presented this week at a Presidential session of the European Cancer Congress has shown.1

“Immunotherapy has long been believed to have the potential to make an impact in kidney cancer, but until now we had not been able to demonstrate such a significant survival benefit. We have a real opportunity to change clinical practice for patients when other therapies have failed,” said principal investigator Padmanee Sharma, MD, PhD, professor, Departments of Genitourinary Medical Oncology and Immunology and scientific director of the Immunotherapy Platform, part of the University of Texas MD Anderson Cancer Center’s Moon Shots Program.

For the international, phase 3 CheckMate-025 study, researchers enrolled 821 patients with advanced renal cell carcinoma who had previously been treated with 1 or 2 antiangiogenic therapies. Patients were randomly assigned to receive either nivolumab or everolimus.

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Results showed that median overall survival was 25 months with nivolumab compared with 19.6 months with everolimus. Objective response rates were 25% with nivolumab and 5% with everolimus.

Of note, researchers found that some patients continued to respond to nivolumab even after treatment ended.

RELATED: New Insights into the Association Between Renal Cell Carcinoma, Hematologic Malignancies

In regard to safety, patients treated with nivolumab experienced less fatigue and nausea than those treated with everolimus and had an improved quality of life.

“Through studies such as CheckMate-025, we are learning to target the patients’ immune systems to fight cancer rather than targeting the tumor itself. This is a new way forward,” Dr. Sharma said.

Nivolumab is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of unresectable or metastatic melanoma and metastatic squamous non-small cell lung cancer.


  1. Breakthrough study demonstrates survival advantage with immune checkpoint inhibitor for advanced kidney cancer patients [news release]. Houston, TX: MD Anderson Cancer Center; September 25, 2015. Accessed September 25, 2015.