Progression-free survival was longer with cabozantinib than with everolimus among patients with renal carcinoma that had progressed after VEGFR-targeted therapy, a new study published online ahead of print in The New England Journal of Medicine has shown.1
For the phase 3 study, researchers sought to evaluate the efficacy of cabozantinib compared with everolimus in patients with renal cell carcinoma that had progressed after treatment with VEGFR-targeted therapy.
Researchers enrolled 658 patients and randomly assigned them to receive cabozantinib 60 mg daily or everolimus 10 mg daily.
Results showed that median progression-free survival was 7.4 months with cabozantinib and 3.8 months with everolimus. Patients in the cabozantinib group had a 42% lower rate of progression or death than patients in the everolimus arm (HR = 0.58; 95% CI: 0.45- 0.75; P<0.001).
Researchers found that objective response rate was 21% and 5% with cabozantinib and everolimus, respectively (P<0.001).
In regard to safety, dose reductions occurred in 60% of patients who received cabozantinib and in 25% of those who received everolimus. Nine percent of patients who received cabozantinib and 10% of those who received everolimus discontinued study treatment due to adverse events.
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Cabozantinib is an oral, small-molecule tyrosine kinase inhibitor that targets VEGFR, MET, and AXL, which have all been shown to play a role in the development of metastatic renal cell carcinoma or in the development of resistance to antiangiogenic drugs.
Cabozantinib is currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of medullary thyroid cancer and is currently undergoing clinical trials for the treatment of various solid tumors.
- Choueiri TK, Escudier B, Powles T, et al. Cabozantinib versus everolimus in advanced renal-cell carcinoma [published online ahead of print September 25, 2015]. N Engl J Med. doi: 10.1056/NEJMoa1510016.