MD Anderson researchers demonstrated a median overall survival benefit of 25 months with nivolumab, a Food and Drug Administration (FDA)-approved immunotherapy agent, compared with 19.6 months for everolimus, a standard treatment for metastatic kidney cancer.
The CheckMate-025 study findings, published by the New England Journal of Medicine, provide definitive evidence that an immune checkpoint inhibitor is a valid treatment strategy for patients with advanced RCC.
Nivolumab, marketed as Opdivo, is used to treat metastatic melanoma and advanced non-small cell lung cancer. CheckMate-025 is an example of how investigators are examining approved immunotherapy drugs to determine potential impact on other tumor types.
"Immunotherapy has long been believed to have the potential to make an impact in kidney cancer, but until now we hadn't 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," says principal investigator Padmanee Sharma, M.D., Ph.D., professor, Genitourinary Medical Oncology and Immunology.
Sharma is a scientific director of MD Anderson's immunotherapy platform, part of MD Anderson's Moon Shots Program. Platform researchers seek to evaluate effective drug combinations, identify new molecules that block or stimulate immune response and understand which patients will benefit from immunotherapy.
"We're learning to target the patients' immune systems to fight cancer rather than targeting the tumor itself," says Sharma. "This is a new way forward."