For the first time, a new drug from the field of immuno-oncology has proven to extend survival for patients with advanced kidney cancer, a patient population with limited treatment options.
In an MD Anderson study, patients taking nivolumab, marketed as Opdivo, had a median survival of 25 months — 5.4 months longer than patients given the drug everolimus, the current standard of care for patients with metastatic kidney cancer.
Opdivo is an immune checkpoint inhibitor — a drug that takes the brakes off the immune system and allows it to attack cancer. It’s currently used to treat metastatic melanoma and advanced non-small cell lung cancer. Scientists have long believed that immunotherapy had the potential to make an impact in kidney cancer.
“Until now, we haven’t been able to demonstrate such a significant survival benefit in patients with advanced kidney cancer. We have a real opportunity to change clinical practice for these patients when other therapies have failed,” says principal investigator Padmanee Sharma, M.D., Ph.D., professor of Genitourinary Medical Oncology and Immunology.
The findings of the trial provide definitive evidence that an immune checkpoint inhibitor is a valid treatment strategy for patients with advanced kidney cancer, and supports a change in the standard-of-care treatment, Sharma says.
In addition to demonstrating increased overall survival, the trial showed that the number of patients who responded to nivolumab was higher than those treated with everolimus.
Of the 821 patients enrolled, 25% responded to nivolumab versus 5% of those treated with everolimus. Among these patients, partial responses were observed in 24% of those treated with nivolumab and 5% of patients treated with everolimus; complete responses were observed in 1% (four patients) treated with nivolumab and fewer than 1% (two patients) treated with everolimus.
Further, among patients who showed a response, the impact was “durable,” according to Sharma. For some patients, even after treatment with nivolumab ended, response to the drug continued.
“The immune system has a memory, so even when treatment has stopped, the body continues to exhibit a long-term response — meaning these patients can live normal lives without progressive disease,” says Sharma.
Finally, the investigators observed fewer treatment-related adverse events, including fatigue and nausea, and improved quality of life, with nivolumab.
These results were so significant that the trial was halted early and the FDA granted “breakthrough therapy designation” to nivolumab, meaning the FDA will expedite its review of the drug for use in patients with advanced kidney cancer.
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