GU Cancers 2019 | Safety and efficacy of nivolumab in mRCC: Final analysis from the NIVOREN study

NIVOREN GETUG-AFU 26 study is a single-arm, prospective real-world Phase II of nivolumab in patients who fail at least one VEGF prior to TKI. So basically, the purpose of this study was to investigate the safety and the activity of nivolumab in real-world practice.

In this study, we enrolled 720 patient across 26 institutions in France and the main messages are the following. The first thing is about safety. The first assessment was on grade 3 or more treatment-related adverse events. And this grade is 17.9%, which is line with what was seen in the pivotal study. Interestingly, we are now able to more characterize those adverse events and they tend to occur in about the first 8 months with a median around 3 months from treatment start. And what is interesting as well is to know a patient that developed grade 3 or more toxicity, is more likely to develop several events with a mean number of 3.1 treatment-related grade 3 or more adverse event.

The second information is about activity. So nivolumab is active in real-world setting in a very similar way with what has been seen in a pivotal study. Response rate was 21%. Overall survival is about 2 years with a similar median follow-up.

Lastly, we were also able to better characterize that IMDC classification is highly prognostic in this population. And the number of risk factor is also highly prognostic. On top of that, we now know that response to nivolumab, assessed by investigator using RECIST assessment, is also a good prognostic factor of overall survival in this patient population.

So taken all together, this is the largest prospective Phase II of nivolumab in real-world setting enrolling patients with poor performance status or low GFR or even brain metastases, non-symptomatic, which highlights that the activity is very similar to what we know from the pivotal study as well as the safety.