Nivolumab plus ipilimumab (NIVO+IPI) demonstrated superior efficacy over sunitinib (SUN) for previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 214, with a manageable safety profile. We report efficacy and safety with extended follow-up amongst Japanese patients.

CheckMate 214 patients received NIVO (3 mg/kg) plus IPI (1 mg/kg) every 3 weeks for four doses, then NIVO (3 mg/kg) every 2 weeks; or SUN (50 mg) once daily for 4 weeks (6-week cycle). This subgroup analysis assessed overall survival (OS), objective response rate (ORR) and progression-free survival (PFS) per investigator in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor-risk and intent-to-treat (ITT) patients and safety (ITT patients).

Of 550 and 546 patients randomized to NIVO+IPI and SUN, 38 and 34, respectively, were Japanese. Of these, 31 (NIVO+IPI) and 29 (SUN) patients were IMDC intermediate/poor-risk. In IMDC intermediate/poor-risk patients with 30 months’ minimum follow-up, there was a delayed trend in OS benefit with NIVO+IPI (hazard ratio [HR] 0.56; 95% confidence interval [CI]: 0.19-1.59; P = 0.2670), and 24-month OS probability favoured NIVO+IPI (84%) versus SUN (76%). The ORR was 39% with NIVO+IPI and 31% with SUN (P = 0.6968). PFS was similar in both treatment arms (HR 1.17; 95% CI: 0.62-2.20; P = 0.6220). Efficacy in ITT patients was similar to IMDC intermediate/poor-risk patients. Grade 3-4 treatment-related adverse event incidence was lower with NIVO+IPI versus SUN (58 versus 91%).

Japanese patients with untreated aRCC in the NIVO+IPI arm had a numerically higher ORR and improved safety profile versus patients in the SUN arm. A delayed OS benefit appears to be emerging with NIVO+IPI. Longer follow-up is needed. identifier: NCT02231749.

Japanese journal of clinical oncology. 2019 Oct 21 [Epub ahead of print]

Yoshihiko Tomita, Tsunenori Kondo, Go Kimura, Takamitsu Inoue, Yoshiaki Wakumoto, Masahiro Yao, Takayuki Sugiyama, Mototsugu Oya, Yasuhisa Fujii, Wataru Obara, Robert J Motzer, Hirotsugu Uemura

Department of Urology, Niigata University, Niigata, Japan., Department of Urology, Tokyo Women’s Medical University Hospital, Tokyo, Japan., Department of Urology, Nippon Medical School Hospital, Tokyo, Japan., Department of Urology, Akita University Hospital, Akita, Japan., Department of Urology, Juntendo University Hospital, Tokyo, Japan., Department of Urology, Yokohama City University Hospital, Yokohama, Japan., Department of Urology, Hamamatsu University Hospital, Hamamatsu, Japan., Department of Urology, Keio University Hospital, Tokyo, Japan., Department of Surgery, Urology, Tokyo Medical and Dental University Hospital, University Hospital of Medicine, Tokyo, Japan., Department of Urology, Iwate Medical University Hospital, Morioka, Japan., Department of Medicine, Memorial Sloan Kettering Cancer, New York, NY, USA., Department of Urology, Kinki University Hospital, Faculty of Medicine, Osakasayama, Japan.