Brain metastases response to nivolumab in patients with renal cell carcinoma (RCC): Prospective analysis from the GETUG-AFU 26 (NIVOREN) trial

Abstract

Background: Nivolumab (N) is a standard of care in patients (pts) with metastatic RCC after failure of 1 or 2 TKIs. Efficacy of N on brain metastases (BM) from RCC is still unknown. Methods: GETUG-AFU 26 (NIVOREN) is a prospective phase 2 trial assessing safety and efficacy of N in real-world mRCC pts population. This trial included pts with BM not requiring steroids. Herein, we report BM response to N and clinical outcomes in this subpopulation. Results: Overall, 81/709 (11%) pts had active BM or history of BM. Among them, 72 with visible BM at baseline and treated with N were included for analysis. IMDC risk groups were: favorable in 13 pts (18%), intermediate in 34 (48%), poor in 24 (34%). N was given in 2nd or 3rd line in 74% of pts. Median follow up was 16.1 months (m). Among 72 pts, 33 (46%) had no prior local therapy for BM, and 39 (54%) had prior local therapy: 29 had radiation therapy (RT) including 25 pts with stereotactic and 4 with whole brain RT, and 10 had prior surgery plus RT. Number of BM at baseline was 1 in 45 pts (62.5%), 2 or 3 in 17 (23.6%), >3 in 10 (13.9%). Median PFS was 2.8m [CI95% 2.5-4.2], 12m-OS was 61.7% [CI95% 48.5-72.5]. Response assessment on BM was available in 64 pts, among which 11 (17.2%) had objective response (Table 1). Under N, neurologic deterioration was observed in 29 pts (41%) and 28 (39%) required steroids. Overall, 35/72 (49%) pts required focal treatment: 27/33 (82%) in untreated pts and 8/39 (20.5%) in previously treated pts. 6m-brain PFS was 24.5% in untreated pts vs 44.8% in previously treated pts. Correlation between systemic RECIST and brain RECIST will be reported. Conclusions: This is the first study to report activity of N in pts with and without prior focal treatment of BM from RCC. In pts without prior BM focal therapy, N efficacy was poor, and most pts required local treatment for brain progression. (Table Presented) .