Real world data from the Italian expanded access program (EAP): updated safety and efficacy results of nivolumab for metastatic renal cell carcinoma (mRCC)

Background: Nivolumab is an anti-PD1 monoclonal antibody that has shown efficacy in patients (pts) with different tumor types and is the first checkpoint inhibitor to show a survival benefit in a randomised phase III trial in pre-treated mRCC. The experience of pts and physicians in routine clinical practice is often different from those in a controlled clinical trial setting. The EAP provided the opportunity to treat patients (pts) in real world clinical practice before market availability of the drug. The aim of this analysis is to evaluate the safety and efficacy of nivolumab in a real world setting in pts with mRCC treated in the nivolumab Expanded Access Programme in Italy. Materials and Methods: Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for mRCC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events using CTCAE v.4.0. Results: Totally, 389 pts were enrolled in the EAP across 95 Italian sites. Preliminary efficacy and safety data of this population have been submitted to ASCO 2017. We will present updated results with a longer follow-up. The final abstract will report the updated results above efficacy and safety.