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

被引：401

作者：

Albiges, Laurence ^{[1
]}

Tannir, Nizar M. ^{[2
]}

Burotto, Mauricio ^{[3
]}

McDermott, David ^{[4
,5
]}

Plimack, Elizabeth R. ^{[6
]}

Barthelemy, Philippe ^{[7
,8
]}

Porta, Camillo ^{[9
]}

Powles, Thomas ^{[10
,11
]}

Donskov, Frede ^{[12
]}

George, Saby ^{[13
]}

Kollmannsberger, Christian K. ^{[14
]}

Gurney, Howard ^{[15
,16
]}

Grimm, Marc-Oliver ^{[17
]}

Tomita, Yoshihiko ^{[18
]}

Castellano, Daniel ^{[19
]}

Rini, Brian, I ^{[20
]}

Choueiri, Toni K. ^{[21
]}

Saggi, Shruti Shally ^{[22
]}

McHenry, M. Brent ^{[23
]}

Motzer, Robert J. ^{[24
]}

机构：

[1] Gustave Roussy, Dept Canc Med, Villejulf, France

[2] Univ Texas MD Anderson Canc Ctr, Dept Genitourinary Med Oncol, Houston, TX 77030 USA

[3] Bradford Hill Clin Res Ctr, Santiago, Chile

[4] Beth Israel Deaconess Med Ctr, Div Med Oncol, Boston, MA 02215 USA

[5] Dana Farber Harvard Canc Ctr, Boston, MA USA

[6] Fox Chase Canc Ctr, Dept Hematol & Oncol, 7701 Burholme Ave, Philadelphia, PA 19111 USA

[7] Hop Univ Strasbourg, Med Oncol Unit, Strasbourg, France

[8] ICANS, Strasbourg, France

[9] Univ Bari A Moro, Bari, Italy

[10] Royal Free NHS Trust, Barts Canc Inst, Dept Urol, London, England

[11] Queen Mary Univ London, London, England

[12] Aarhus Univ Hosp, Dept Oncol, Aarhus, Denmark

[13] Roswell Park Canc Inst, Dept Med, Buffalo, NY 14263 USA

[14] British Columbia Canc Agcy, Dept Med, Vancouver, BC, Canada

[15] Westmead Hosp, Dept Med Oncol, Westmead, NSW, Australia

[16] Macquarie Univ, Sydney, NSW, Australia

[17] Jena Univ Hosp, Dept Urol, Jena, Thuringen, Germany

[18] Niigata Univ, Fac Med, Grad Sch Med & Dent Sci, Niigata, Japan

[19] Hosp Univ 12 Octubre, Med Oncol Serv, Madrid, Spain

[20] Vanderbilt Univ, Med Ctr, Div Hematol Oncol, Nashville, TN USA

[21] Dana Farber Canc Inst, Lank Ctr Genitourinary Oncol, Boston, MA 02115 USA

[22] Bristol Myers Squibb, Dept Clin Trials, Princeton, NJ USA

[23] Bristol Myers Squibb, Dept Biostat, Princeton, NJ USA

[24] Mem Sloan Kettering Canc Ctr, Dept Med, 1275 York Ave, New York, NY 10021 USA

来源：

ESMO OPEN | 2020年 / 5卷 / 06期

基金：

美国国家卫生研究院;

关键词：

checkmate; 214; nivolumab plus ipilimumab; advanced renal cell carcinoma; dual checkpoint inhibition; long-term follow-up;

D O I：

10.1136/esmoopen-2020-001079

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

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 x4 doses, followed by NIVO (3 mg/kg) every two weeks; or SUN (50 mg) once per day x4 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.

引用

页数：10

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