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    Immunotherapy shows survival benefit in advanced RCC

    Nivolumab, an immunotherapy drug, has shown a significant survival benefit in patients with metastatic renal cell carcinoma and has been granted breakthrough therapy designation from the FDA for the potential indication of metastatic RCC.

    Researchers say the study marks the first time an immune checkpoint inhibitor has been proven to increase survival among patients with advanced RCC.

    Read - Best of AUA 2015: Kidney Cancer

    For the CheckMate-025 study, researchers at the University of Texas MD Anderson Cancer Center, Dallas, compared nivolumab, an FDA-approved immunotherapy agent, with everolimus (Afinitor). Nivolumab, an immune checkpoint inhibitor marketed as Opdivo, is currently used to treat metastatic melanoma and advanced non-small cell lung cancer.

    “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, in a press release from MD Anderson.

    In the randomized phase III clinical trial, which was published online in the New England Journal of Medicine (Sept. 25, 2015) and presented at the European Cancer Congress in Vienna, Austria, patients whose disease progressed on antiangiogenic therapies were treated with either nivolumab or everolimus. Median overall survival was 5.4 months longer with nivolumab (25 months) compared with everolimus (19.6 months).

    The study included 821 patients with advanced RCC across 151 sites in 24 countries in North America, Europe, Australia, South America, and Asia. All had previously been treated with one or two antiangiogenic therapies. The median duration of treatment was 5.5 months with nivolumab and 3.7 months with everolimus.

    NEXT: Higher objective response rate with nivolumab

    Benjamin P. Saylor
    Saylor is content managing editor for Urology Times.


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