Background
CheckMate 214 demonstrated a significantly higher overall survival (OS) and objective response rate with Nivolumab plus Ipilimumab than with Sunitinib among intermediate and poor risk patients with previously untreated advanced renal cell carcinoma (RCC).1 Nivolumab with Ipilimumab was subsequently approved on PBS in Australia from March 2019.2
Aims
Our objective was to assess the efficacy and safety of combination immunotherapy for RCC in a real-world population as compared to the CheckMate 214 trial.
Methods
This was a retrospective multi-centre observational study assessing patients at The Canberra Hospital and Royal North Shore Hospital who have been started on this combination of immunotherapy since PBS approval.
Results
25 patients were on combination immunotherapy at our two centres. Compared to CheckMate 214, within the limits of a small sample size and limited follow up duration (median follow up 12.9months) given recency of PBS approval, our efficacy was lower (12month OS 61.8% compared with 90%) though with an improved safety profile (Grade 3/4 events 56% compared with 79%). Our patients had higher risk features (number of metastases, percentage of IMDC poor risk and histological subtype) and included patients who would have been excluded from the Checkmate 214.
Conclusions
In a real-world population that had higher risk features, efficacy was lower though the safety profile was improved, supporting other real-world data published in other countries since our data collection integral to help guide ongoing effective use of the combination in this population.