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GU Symposium 2016: Cabozantinib Improves Upon the Standard of Care for Advanced Kidney Cancer

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Key Points

  • Early findings from the first 375 patients showed that cabozantinib improved the median progression-free survival compared to everolimus (7.4 vs 3.8 months).
  • The new analysis of data from all 658 patients showed that 75% of patients treated with cabozantinib experienced tumor shrinkage, compared to 48% of everolimus-treated patients.
  • Researchers found that progression-free survival improvements associated with cabozantinib vs everolimus were consistent across patient subgroups such as risk category, tumor burden, and prior therapy.

New analyses from a phase III clinical trial of patients with previously treated advanced kidney cancer demonstrated that patients of all risk levels experience more benefit from cabozantinib (Cometriq) than from the current standard of care, everolimus (Afinitor). The greater activity of cabozantinib was independent of metastatic sites, the number of prior treatments, and the type of treatments administered. The study was presented by Escudier et al at the 2016 Genitourinary Cancers Symposium in San Francisco (Abstract 499).

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

Renal cell carcinoma is the most common type of kidney cancer, and its incidence is increasing worldwide. Standard treatments include two classes of targeted drugs: vascular endothelial growth factor receptor (VEGFR) inhibitors and mammalian target of rapamycin (mTOR) inhibitors, such as everolimus. Cabozantinib blocks the growth of tumor blood vessels and the key signaling pathways that drive tumor growth and spread.

Study Findings

In the trial, 658 patients with advanced renal cell carcinoma who had previously received VEGFR inhibitor therapy were randomly assigned to receive cabozantinib or everolimus. Early findings from the first 375 patients showed that cabozantinib improved the median progression-free survival compared to everolimus (7.4 vs 3.8 months).

The new analysis of data from all 658 patients showed that the great majority (75%) of patients treated with cabozantinib experienced tumor shrinkage, compared to 48% of everolimus-treated patients. In addition, an early evaluation of overall survival showed a trend for improved survival for patients receiving cabozantinib compared to everolimus.

Researchers found that progression-free survival improvements associated with cabozantinib vs everolimus 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). Furthermore, researchers found that patients who had liver metastases or a combination of visceral and bone metastases also benefited 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.

Cabozantinib is currently FDA approved for treatment of patients with a specific form of thyroid cancer. It is being tested in clinical trials for a wide range of cancer types.

This study received funding from Exelixis, Inc. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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