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Albiges L , Tannir NM , Burotto M , McDermott D , Plimack ER , Barthélémy P , Porta C , Powles T , Donskov F , George S , Kollmannsberger CK , Gurney H , Grimm MO , Tomita Y , Castellano D , Rini BI , Choueiri TK , Saggi SS , McHenry MB , Motzer RJ
Nivolumab plus ipilimumab versus sunitinib for first-line treatment of advanced renal cell carcinoma: extended 4-year follow-up of the phase III CheckMate 214 trial
ESMO Open. 2020 Nov;5(6) :e001079
PMID: 33246931    PMCID: PMC7703447    URL: https://www.ncbi.nlm.nih.gov/pubmed/33246931
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PURPOSE: To report updated analyses of the phase III CheckMate 214 trial with extended minimum follow-up assessing long-term outcomes with first-line nivolumab plus ipilimumab (NIVO+IPI) versus (vs) sunitinib (SUN) in patients with advanced renal cell carcinoma (aRCC). METHODS: Patients with aRCC with a clear cell component were stratified by International Metastatic Renal Cell Carcinoma Database Consortium risk and randomised to NIVO (3 mg/kg) plus IPI (1 mg/kg) every three weeks ×4 doses, followed by NIVO (3 mg/kg) every two weeks; or SUN (50 mg) once per day ×4 weeks (6-week cycle). Efficacy endpoints included overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) per independent radiology review committee in patients with intermediate/poor-risk disease (I/P; primary), intent-to-treat patients (ITT; secondary) and in patients with favourable-risk disease (FAV; exploratory). RESULTS: Overall, 1096 patients were randomised (ITT: NIVO+IPI, n=550, SUN, n=546; I/P: NIVO+IPI, n=425, SUN, n=422; FAV: NIVO+IPI, n=125, SUN, n=124). After 4 years minimum follow-up, OS (HR; 95% CI) remained superior with NIVO+IPI vs SUN in ITT (0.69; 0.59 to 0.81) and I/P patients (0.65; 0.54 to 0.78). Four-year PFS probabilities were 31.0% vs 17.3% (ITT) and 32.7% vs 12.3% (I/P), with NIVO+IPI vs SUN. ORR remained higher with NIVO+IPI vs SUN in ITT (39.1% vs 32.4%) and I/P (41.9% vs 26.8%) patients. In FAV patients, the HRs (95% CI) for OS and PFS were 0.93 (0.62 to 1.40) and 1.84 (1.29 to 2.62); ORR was lower with NIVO+IPI vs SUN. However, more patients in all risk groups achieved complete responses with NIVO+IPI: ITT (10.7% vs 2.6%), I/P (10.4% vs 1.4%) and FAV (12.0% vs 6.5%). Probability (95% CI) of response ≥4 years was higher with NIVO+IPI vs SUN (ITT, 59% (0.51 to 0.66) vs 30% (0.21 to 0.39); I/P, 59% (0.50 to 0.67) vs 24% (0.14 to 0.36); and FAV, 60% (0.41 to 0.75) vs 38% (0.22 to 0.54)) regardless of risk category. Safety remained favourable with NIVO+IPI vs SUN. CONCLUSION: After long-term follow-up, NIVO+IPI continues to demonstrate durable efficacy benefits vs SUN, with manageable safety. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov identifier: NCT02231749.
2059-7029 Albiges, Laurence Orcid: 0000-0002-5734-3480 Tannir, Nizar M Burotto, Mauricio McDermott, David Plimack, Elizabeth R Barthélémy, Philippe Porta, Camillo Orcid: 0000-0003-2412-1563 Powles, Thomas Donskov, Frede George, Saby Kollmannsberger, Christian K Gurney, Howard Grimm, Marc-Oliver Tomita, Yoshihiko Castellano, Daniel Rini, Brian I Choueiri, Toni K Saggi, Shruti Shally McHenry, M Brent Motzer, Robert J Journal Article England ESMO Open. 2020 Nov;5(6):e001079. doi: 10.1136/esmoopen-2020-001079.