911PPatients (pts) with metastatic non-clear cell renal cell carcinoma (mnccRCC) treated with Nivolumab (Nivo) based immunotherapy as advanced treatment (ATL) line: analysis of a national early access program (EAP)

Background: Immunotherapy with the andi-PD1 Nivo is a standard ATL for clear cell mRCC. Data on its activity in the rare variant of mnccRCC is limited (case reports). We aimed to report the activity of Nivo in mnccRCC pts treated per a national EAP. Methods: Records from consecutive mnccRCC pts treated with Nivo ATL per a national EAP in 6 centers were retrospectively reviewed. We report the clinical benefit, progression free survival (PFS), overall survival (OS), and toxicity. Results: Between 7/2015 – 12/2016, 16 mnccRCC pts (median age 64, male 68%; papillary type 38%, n = 6; chromophobe 44%, n = 7; undifferentiated 12%, n = 2; pure sarcomatoid 6%, n = 1). 62% (n = 10) were treated with second line Nivo, and 38% (n = 6) as third and fourth line. Heng risk was good/intermediated/poor in 6% (n = 1)/75% (n = 12)/19% (n = 3). Clinical benefit (stable disease+ partial response) was 37% (4 partial response and 2 stable disease). Median PFS was 3.5 months (mos). After a median follow up time of 8 mos, 100% of the pts with a clinical benefit are still with a benefit and on treatment (range 5-18m). Most pts (69%, n = 11) are alive, with median OS not reached. Toxicity was mild grade 1-2 in the majority of pts (56%, n = 9). Conclusions: Nivo as ATL may be active in mnccRCC pts, and associated with durable responses and predictable mild toxicity. Future and larger studies are needed to assess the activity of immunotherapy in this uncommon type of mRCC. Legal entity responsible for the study: the author Funding: None Disclosure: All authors have declared no conflicts of interest.