Two pivotal studies published in the New England Journal of Medicine and conducted by Memorial Sloan Kettering researchers offer proof of better treatment options for patients with advanced renal cell carcinoma (RCC), the most common form of kidney cancer.
In the studies, nivolumab (Opdivo®) and cabozantinib improved overall survival and progression-free survival, respectfully, versus the current standard of care for metastatic RCC, everolimus (Afinitor®). The trials’ results were so impressive that the US Food and Drug Administration (FDA) has given both drugs breakthrough status as a treatment for RCC. Results from both studies are being presented at the 2015 European Cancer Congress (ECC) in Vienna, Austria, on September 26.
Nivolumab Shown to Be More Effective and Extend Survival
The first research study, led by MSK medical oncologist Robert J. Motzer, shows that nivolumab improves overall survival in previously treated patients with advanced RCC. In the randomized phase III trial, 821 patients with advanced RCC previously treated with one or two antiangiogenic therapies received nivolumab intravenously every two weeks or a 10 mg tablet of everolimus orally once daily. Participants had a median overall survival rate of approximately 25 months with nivolumab compared with an overall survival rate of about 19 months with everolimus.
“Although everolimus and other agents have changed the therapeutic landscape for this disease, the treatments offer only limited overall survival,” says Dr. Motzer. “Renal cell carcinoma is a disease that is crying out for new and novel treatment strategies, and this trial has produced practice-changing results in a cancer that is highly resistant to other therapies.”
Additionally, fewer treatment-related adverse side effects occurred with nivolumab (19 percent) compared with everolimus (37 percent). The most frequent adverse effects were nausea and fatigue in the nivolumab patients and fatigue and stomatitis in the everolimus patients.
Cabozantinib Reduced Rate of Disease Progression or Death
In another study led in part by Dr. Motzer, a drug called cabozantinib improved progression-free survival in patients with advanced RCC when compared with everolimus.
The study was a randomized phase II clinical trial in patients with RCC whose disease had progressed despite treatment with at least one vascular endothelial growth factor receptor (VEGFR)-targeted therapy.
Cabozantinib reduced the rate of disease progression or death by 42 percent compared with everolimus. Everolimus was used as a comparison because it’s the standard treatment for patients who have progressed after receiving a VEGFR-targeted therapy.
“Over the past ten years, we have made considerable progress against advanced kidney cancers with the development of targeted drugs in phase III trials led by MSK,” says Dr. Motzer. “The phase III trials of nivolumab and cabozantinib established an improved outcome over standard treatment with everolimus in resistant tumors, and pending regulatory approval will provide two new treatment options. Both of these new drugs will contribute to the progress we’re making against this malignancy.”