Cabozantinib improves overall survival compared with everolimus in patients with advanced or metastatic clear-cell renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy, according to the final results of the phase 3 METEOR trial presented June 5 at the American Society of Clinical Oncology annual meeting in Chicago and published the same day in The Lancet Oncology (S1470-2045(16)30107-3).

At a median follow-up of about 19 months, the median survival time was 21.4 months for cabozantinib-treated patients and 16.5 months for everolimus recipients, a difference corresponding to a significant 34% decreased risk of death, researchers led by Toni K. Choueiri, MD, of the Dana-Farber Cancer Institute in Boston, reported.

Final results also showed that cabozantinib treatment decreased the risk of progression by a significant 49% compared with everolimus and improved objective response (17% vs 3%).

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On April 25, the FDA approved cabozantinib (Cabometyx), an oral inhibitor of tyrosine kinases including MET, VEGFR, and AXL, for the treatment of patients with advanced RCC who previously received anti-angiogenic therapy.

In the open-label METEOR trial, investigators randomly assigned 658 patients with advanced or metastatic clear-cell RCC and prior treatment with at least 1 VEGFR tyrosine kinase inhibitor to receive either 60 mg cabozantinib once daily (330 patients) or 10 mg everolimus once daily (328 patients).

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The most common grade 3 or 4 adverse events (AEs) included hypertension (15% in the cabozantinib group and 4% in the everolimus group), diarrhea (13% and 2%, respectively), and fatigue (11% and 7%, respectively). Serious AEs (grade 3 or worse) occurred in 39% of the cabozantinib group and 40% of everolimus recipients.

The METEOR trial previously had demonstrated improved progression-free survival and objective response rate with cabozantinib versus everolimus, as Dr. Choueiri and colleagues reported in The New England Journal of Medicine (2015;373:1814-1823).