A recent study reports the real-world safety and efficacy of nivolumab from metastatic renal cell carcinoma (RCC) patients on an expanded access programme in Italy.
In all, 389 patients received nivolumab 3 mg/kg every other week. The objective response rate was 23.1%, and the median progression-free survival was 4.5 months. The 12-month overall survival rate was 63%. During this time, there were no treatment-related deaths, 5.7% patients discontinued their treatment due to adverse events, and the most common adverse events were fatigue and rash (13% and 9%, respectively).
These results are consistent with the findings from the CheckMate 025 trial, which was used for the nivolumab product license application. The trial suggests that patients who have failed VEGF therapy may gain benefit from nivolumab. Furthermore, results from this trial suggest nivolumab could be used to treat elderly patients with non-clear-cell metastatic RCC, who have been treated with everolimus, and had bone and/or brain metastases.