SAN FRANCISCO, CA—Cabozantinib improved progression-free survival in patients with advanced renal cell carcinoma compared with everolimus. These findings of the randomized, phase 3 METEOR trial were reported at the 2016 Genitourinary Cancer Symposium.

Renal cell carcinoma (RCC) is the most common type of kidney cancer and has an increasing incidence worldwide. Two classes of targeted drugs are now standard treatments: vascular endothelial growth factor receptor (VEGFR) inhibitors and mammalian target of rapamycin (mTOR) inhibitors, such as everolimus.

Cabozantinib works by blocking the growth of tumor blood vessels and the key signaling pathways that drive tumor growth and spread; its targets include VEGFRs, MET, and AXL.

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This trial enrolled 658 patients with advanced RCC who had been treated with prior inhibitors of VEGFR and had progressed during treatment or within 6 months of the last dose of their most recent VEGFR inhibitor. The enrolled patients were randomized 1:1 to receive either cabozantinib or everolimus.

Earlier findings from the first 375 patients showed that cabozantinib improved the median progression-free survival compared with everolimus (7.4 months vs. 3.8 months).

Based on the new analysis of data from all 658 patients, cabozantinib led to tumor shrinkage in 75% of the patients who received it vs 48% of patients treated with everolimus. Overall survival showed a trend toward improvement with cabozantinib over everolimus in an early analysis.

The improvements in progression-free overall survival associated with cabozantinib were consistent across patient subgroups. The subgroups were defined by risk category (favorable, intermediate, or poor risk), tumor burden, and prior therapy (type, number, and duration).

Patients who had liver metastases or a combination of visceral and bone metastases were found to benefit more from cabozantinib.

The most common side effects related to cabozantinib were diarrhea, fatigue, nausea, decreased appetite, and hand-foot syndrome. The most common side effects associated with everolimus included fatigue, anemia, decreased appetite, cough, and dyspnea. Treatment side effects were successfully managed with supportive care and dose modifications.

Currently, cabozantinib is FDA-approved for treating a specific type of thyroid cancer. It is being tested for a wide range of cancer types in clinical trials.

The METEOR trial was funded by Exelixis, Inc.