CheckMate 214 post-hoc analyses of nivolumab plus ipilimumab or sunitinib in IMDC intermediate/poor-risk patients with previously untreated advanced renal cell carcinoma with sarcomatoid features.

• DOI: 10.1200/jco.2019.37.15_suppl.4513
• Publication Date: 2019-05-27T16:08:36Z
• Authors: David F. McDermott; Toni K. Choueiri; Robert J. Motzer; Osvaldo Rudy Aren; Saby George; Thomas Powles; Frede Donskov; Michael Roger Har...; Jeronimo Rafael R...; Yuko Ishii; M. Brent McHenry; Sabeen Fatima Mekan; Brian I. Rini; Nizar M. Tannir
• Keywords: Post-hoc analysis

4513 Background: Patients (pts) with advanced renal cell carcinoma sarcomatoid features (sRCC) have poor prognosis and suboptimal outcomes anti-VEGF targeted therapy. Nivolumab plus ipilimumab (N+I) demonstrated superior objective response rate (ORR) overall survival (OS) vs sunitinib (S) in previously untreated pts International Metastatic RCC Database Consortium (IMDC) intermediate/poor (I/P)-risk, clear-cell, the phase 3 CheckMate 214 trial. Methods: We performed a post-hoc exploratory analysis of N+I S sRCC pts. The presence was assessed by keyword search for “sarcomatoid” available local pathology reports accompanying pretreatment tumor samples. Results: 842 (77%) 1096 intention-to-treat had available, including 112 randomized I/P-risk (N+I, n = 60; S, 52). Baseline characteristics were balanced between arms. Notably, 47% 53% arms PD-L1 expression ≥1% at baseline, which higher than all 26% 29%). In descriptive analyses minimum follow-up 30 months, confirmed ORR complete per investigator (RECIST v1.1), OS, progression-free (PFS) improved (Table). No new safety signals seen Conclusions: this subgroup 214, promising efficacy prolonged consistent safety, untreated, I/P-risk, clear-cell features. Prospective studies that include are ongoing. Clinical trial information: NCT02231749. [Table: see text]