Cabozantinib significantly improves progression-free survival in patients with advanced clear-cell renal cell carcinoma (RCC) compared with everolimus, the current standard of care, according to study findings that will be presented at the 2016 Genitourinary Cancers Symposium in San Francisco.

Investigators even observed benefits in patients with prior treatment, brain metastasis, and exposure to immune-based therapies.

“This is one more example of how precision medicine is paying off for patients,” Sumanta Pal, MD, a spokesperson for the American Society of Clinical Oncology (ASCO), a co-sponsor of the symposium, said in a press release. “By fine-tuning the way we target molecular pathways that tumors rely on to grow, we’re seeing greater benefits for patients with advanced kidney cancer. As we await longer-term survival data, these are striking early signs of success.”

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The study subjects were participants in METEOR, a phase 3 clinical trial. The study included patients with metastatic RCC that progressed after prior therapy with vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (e.g., sorafenib, sunitinib, axitinib, pazopanib, or tivozanib). Investigators randomly assigned 330 patients to once-daily oral cabozantinib (60 mg) and 328 patients to everolimus (10 mg).

Cabozantinib improved median progression-free survival compared with everolimus (7.4 months vs. 3.8 months). The odds of cancer progression were 48% lower with cabozantinib. Three-quarters of patients treated with cabozantinib experienced tumor shrinkage, compared with nearly half of everolimus-treated patients. A favorable trend in overall survival supported these results, according to the investigators.

“Current treatments can provide some benefit to patients with advanced kidney cancer, but we need treatments that are more effective,” lead study author Bernard Escudier, MD, Chair of the Genitourinary Oncology Committee at the Institut Gustave Roussy in Villejuif, France, stated in a press release. “Our preliminary results suggest that cabozantinib may help overcome treatment resistance and provide new hope to patients with this aggressive cancer.”

Cabozantinib, a small molecule kinase inhibitor, impedes the growth of tumor blood vessels and the signaling that promotes tumor growth and spread.

Progression-free survival improved across patient subgroups defined by risk category, tumor burden, and prior therapy (type, number, and duration). Researchers also observed that patients who had liver metastases or a combination of visceral and bone metastases benefited more from cabozantinib than everolimus.

Cabozantinib is currently approved for thyroid cancer and is being investigated for other cancers. The most common side effects of the drug were diarrhea, fatigue, nausea, decreased appetite, and hand-foot syndrome.


  1. Cabozantinib Improves Upon the Standard of Care for Advanced Kidney Cancer [press release]. San Francisco, CA. American Society of Clinical Oncology; January 4, 2016.
  2. Pal S. and Escudier B. Genitourinary Cancers Symposium 2016 Presscast . American Society of Clinical Oncology; January 4, 2016.
  3. Escudier BJ, Motzer RJ, Powles T, et al. Subgroup analyses of METEOR, a randomized phase 3 trial of cabozantinib versus everolimus in patients (pts) with advanced renal cell carcinoma (RCC). J Clin Oncol 34, 2016 [suppl 2S; abstr 499].