FDA Approves Nivolumab and Cabozantinib for Renal Cell Carcinoma

On January 22, 2021, the United States Food and Drug Administration approved the combination of cabozantinib and nivolumab for the first-line treatment of patients with advanced renal cell carcinoma. Results were based off of the CheckMate 9ER clinical trial. This was an open label randomized trial, in patients with untreated advanced renal cell carcinoma. Patients were randomized to either a combination of nivolumab 240 mg (An alternative dosing option was for 180 mg every 4 weeks for the nivolumab.) every 2 weeks plus cabozantinib 40 mg daily, versus sunitinib 50 mg daily. Sunitnib was given on a 4-week on 2-week off cycle. The median progression free survival was reported at 16.6 versus 8.3 months. The hazard ratio was 0.51, with a 95% confidence interval of 0.41–0.64. The median overall survival was not reached in either arm, with a hazard ratio of 0.60. The overall response rate for the combination was 55.7%. The overall response rate for single agent sunitinib was 27.1%. Diarrhea was the most common adverse event seen in up to 25% of patients. Other important adverse events included hand-foot syndrome as well as fatigue and hepatotoxicity.