Cabometyx Improves Survival in Renal Cell Carcinoma

Previously treated patients with advanced renal cell carcinoma saw a higher overall survival rate with Cabometyx when compared to those on Afinitor, according to a phase 3 study. 
BY JASON M. BRODERICK @jasoncology
Cabometyx (Cabozantinib) reduced the risk of death by 34 percent compared with Afinitor (everolimus) in patients with previously treated advanced renal cell carcinoma (RCC), according to updated data from the phase 3 METEOR trial presented at the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO), a gathering of 30,000 oncology professionals in Chicago.

The results, which were simultaneously published in The Lancet Oncology showed a 4.9-month median overall survival (OS) benefit with the multikinase inhibitor Cabometyx. The risk of disease progression was reduced by 49 percent with Cabometyx versus Afinitor.

Based on the METEOR trial, the FDA approved Cabometyx in April 2016 for patients with advanced RCC who had prior antiangiogenic therapy.

“In the phase 3 METEOR trial, treatment with Cabometyx was associated with a significant improvement in overall survival, as well as progression-free survival and objective response rate compared with Afinitor in patients with advanced renal cell carcinoma. Cabometyx is a new standard for patients with advanced RCC after prior antiangiogenic therapy,” said lead author Toni Choueiri, clinical director, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute.

In the METEOR study, 658 patients with clear cell RCC were randomized and given either Cabometyx or Afinitor daily. The median age of patients was approximately 62 years.

A majority of patients in each arm had received one prior vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR TKI), with approximately 30 percent of patients having received two or greater prior VEGFR TKIs. Use of prior VEGFR TKIs included Sutent (sunitinib), Votrient (pazopanib), Inlyta (axitinib) and Nexavar (sorafenib). The rates of prior cytokines, PD-1/PD-L1 agents and Avastin (bevacizumab) between the Cabometyx and Afinitor arms were similar as well, at 12 percent versus 16 percent, 5 percent versus 4 percent and 2 percent versus 3 percent, respectively.

Across the study, approximately 33 percent of patients had received radiotherapy and 86 percent of patients had undergone surgery to remove the kidneys.

Median OS was 21.4 months for patients receiving Cabometyx versus 16.5 months for those receiving Afinitor. The OS benefit with Cabometyx was sustained across all prespecified patient subgroups, including MSKCC risk groups, prior VEGFR TKIs, bone metastases, visceral bone metastases and tumor MET status.

Commenting on the MET subgroup, Choueiri said, “The hazard ratio for overall survival in the MET-high versus MET-low expression group does suggest that patients do experience clinical benefit with Cabometyx regardless of MET expression level. This could reflect the broader target profile of Cabometyx.”

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