The Food and Drug Administration (FDA) in the United States has approved the cabozantinib (Cabometyx) plus nivolumab (Opdivo) combination for first-line treatment of advanced renal cell carcinoma (RCC) based on the results of the Checkmate 9ER trial.
Around 20-30% of people are diagnosed with advanced RCC, and 30% of people treated for early stage RCC go on to develop advanced disease. This highlights the significant unmet need for effective first-line treatments that delay disease progression and are tolerable for patients.
The Checkmate 9ER trial showed that there was a statically significant improvement in progression-free survival, overall survival and overall response rate for patients on the cabozantinib/nivolumab combination treatment in comparison to those treated with sunitinib. Median progression-free survival was 16.6 months for patients on the combination treatment compared to 8.3 months for those on sunitinib. Overall response rate was 55.7% versus 27.1% for sunitinib, and median overall survival was not reached.
The cabozantinib plus nivolumab combination is currently being reviewed by the European Medicines Agency (EMA) for use within Europe and the Medicines and Healthcare products Regulatory Agency (MHRA) for use within the UK.