Results from the phase III METEOR clinical trial, which compares cabozantinib (Cabometxy) with everolimus (Afinitor) in patients with advanced renal cell carcinoma (RCC) who have had prior anti-angiogenic therapy, were presented at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago last week. The results showed almost a 30% increase in overall survival (OS) compared to everolimus. After almost 19 months of follow-up, median OS for patients treated with cabozantinib was 21.4 months compared to 16.5 months for everolimus. There was a 34% reduction in the risk of death with cabozantinib.
Cabozantinib was approved by the US Food and Drug Administration (FDA) in April 2016 and submitted for a marketing authorisation to the European Medicines Agency (EMA) in January 2016. Cabozantinib has been granted accelerated assessment status by the EMA’s Committee for Medicinal Products for Human Use (CHMP), meaning the marketing authorisation application may be eligible for a 150-day review, versus the standard 210 days.
Cabozantinib is the only drug to demonstrate significant benefit to patients in overall survival, progression-free survival and overall response rate in a phase III trial in previously treated advanced RCC.