Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: Analysis of Japanese patients in CheckMate 214 with extended follow-up Journal Article


Authors: Tomita, Y.; Kondo, T.; Kimura, G.; Inoue, T.; Wakumoto, Y.; Yao, M.; Sugiyama, T.; Oya, M.; Fujii, Y.; Obara, W.; Motzer, R. J.; Uemura, H.
Article Title: Nivolumab plus ipilimumab versus sunitinib in previously untreated advanced renal-cell carcinoma: Analysis of Japanese patients in CheckMate 214 with extended follow-up
Abstract: Background 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. Methods 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). Results 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%). Conclusions 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. https://clinicaltrials.gov/ct2/show/NCT02231749?term=NCT02231749&rank=1 identifier: NCT02231749.
Keywords: ipilimumab; japanese; therapies; first-line treatment; nivolumab; advanced renal cell carcinoma
Journal Title: Japanese Journal of Clinical Oncology
Volume: 50
Issue: 1
ISSN: 0368-2811
Publisher: Oxford University Press  
Date Published: 2020-01-01
Start Page: 12
End Page: 19
Language: English
ACCESSION: WOS:000515114200003
DOI: 10.1093/jjco/hyz132
PROVIDER: wos
PMCID: PMC6978670
PUBMED: 31633185
Notes: Article -- Source: Wos
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  1. Robert Motzer
    928 Motzer