609

Background: N+I demonstrated superior OS and ORR v S in intention-to-treat (ITT) and intermediate/poor-risk (IP) pts with aRCC in CheckMate 214. Here, we report OS, response outcomes per independent radiology review committee (IRRC), and safety with extended min follow-up of 42 mo. Methods: Pts with clear cell aRCC were randomized 1:1 to N 3 mg/kg + I 1 mg/kg Q3W×4 and then N 3 mg/kg Q2W, or S 50 mg daily for 4 wk on, 2 wk off. Endpoints were OS, ORR, and PFS per IRRC using RECIST v1.1 in IP (primary), ITT (secondary), and favorable pts (FAV; exploratory). Results: OS remained superior in ITT (HR 0.72) and IP (HR 0.66) pts with N+I v S (Table). ORR per IRRC was higher and more responses were ongoing with N+I v S (68% v 53% [ITT] and 68% v 52% [IP]). More pts achieved complete response (CR) with N+I and these were ongoing in 86% [ITT] and 84% [IP] of pts. The PFS probability with N+I stabilized after 24 mo at ~35% in ITT and IP pts, whereas probabilities declined over time with S. Among FAV pts, while ORR was 29% with N+I v 54% with S, more pts achieved CR (13% v 6%), and more responses were ongoing (69% v 54%) with N+I v S; 94% of CRs in FAV pts were ongoing with N+I. OS benefits were similar in both arms and PFS probabilities are stabilizing with N+I and declining with S in FAV pts. The incidence of any and grade 3–4 treatment-related AEs was consistent with previous reports and no new drug-related deaths occurred in either arm. Response outcomes per investigator will also be reported. Conclusions: Superior OS and ORR with N+I v S was maintained in ITT and IP pts. More pts treated with N+I experienced CR compared with S, responses and CRs were durable, and PFS probabilities stabilized with N+I after extended follow-up. No new safety signals emerged. Clinical trial information: NCT02231749.

Arm; nITT
IP
N+I; 550S; 546N+I; 425S; 422
OS, HR (95% CI)0.72 (0.61–0.86)0.66 (0.55–0.80)
OS, %
24 mo71616652
36 mo59515544
48 mo53445036
ORR per IRRC, %(95%CI)39 (35–43)33 (29–37)42 (37–47)26 (22–31)
CR, %112101
PFS per IRRC, HR (95% CI)0.89 (0.76–1.05)0.76 (0.63–0.91)
PFS per IRRC, %
24 mo38343726
36 mo34253520
48 mo34173513
PFS per IRRC in responders, %n = 215n = 178n = 179n = 111
24 mo70636855
36 mo66446540
48 mo66346533

© 2020 American Society of Clinical Oncology

Research Sponsor:

Bristol-Myers Squibb

COMPANION ARTICLES

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ARTICLE CITATION

DOI: 10.1200/JCO.2020.38.6_suppl.609 Journal of Clinical Oncology 38, no. 6_suppl (February 20, 2020) 609-609.

Published online February 19, 2020.

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