CheckMate 025 phase III trial: Outcomes by key baseline factors and prior therapy for nivolumab (NIVO) versus everolimus (EVE) in advanced renal cell carcinoma (RCC).

Genitourinary Cancer
Session Type and Session Title: 
Poster Session C: Renal Cell Cancer
General Session 9: Clear and Non–Clear Cell Renal Cancer
Abstract Number: 


Poster Board Number: 
Poster Session C Board #D3
J Clin Oncol 34, 2016 (suppl 2S; abstr 498)
Robert J. Motzer, Padmanee Sharma, David F. McDermott, Saby George, Hans J. Hammers, Sandhya Srinivas, Scott S. Tykodi, Jeffrey Alan Sosman, Giuseppe Procopio, Elizabeth R. Plimack, Daniel E. Castellano, Howard Gurney, Frede Donskov, Petri Bono, John Wagstaff, Thomas Christoph Gauler, Takeshi Ueda, Huanyu Zhao, Ian M Waxman, Bernard Escudier; Memorial Sloan Kettering Cancer Center, New York, NY; The University of Texas MD Anderson Cancer Center, Houston, TX; Beth Israel Deaconess Medical Center, Boston, MA; Roswell Park Cancer Institute, Buffalo, NY; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Stanford University Medical Center, Stanford, CA; University of Washington, Seattle Cancer Care Alliance, Seattle, WA; Vanderbilt University Medical Center, Nashville, TN; Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy; Fox Chase Cancer Center, Philadelphia, PA; Hospital Universitario 12 de Octubre, Madrid, Spain; Westmead Hospital, Westmead, Australia; Department of Oncology, Aarhus University Hospital, Aarhus, Denmark; Helsinki University Central Hospital, Helsinki, Finland; South West Wales Cancer Institute, Swansea, United Kingdom; Department of Radiotherapy, University Hospital Essen, Essen, Germany; Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan; Bristol-Myers Sqiubb, Princeton, NJ; Bristol-Myers Squibb, Princeton, NJ; Institut Gustave Roussy, Villejuif, France

Abstract Disclosures


Background: Based on assessment by an independent Data Monitoring Committee, a phase III trial of NIVO (n=410) vs EVE (n=411) in previously treated patients with advanced or metastatic RCC (NCT01668784) was halted early as it met its endpoint; superior overall survival (OS) was seen with NIVO vs EVE. We present outcomes by key baseline factors, prior therapy, and subsequent anticancer therapy. Methods: Patients with 1 or 2 prior anti-angiogenic therapies and measurable disease (RECIST v1.1) were randomized 1:1 to NIVO 3 mg/kg IV every 2 weeks or EVE 10 mg orally once daily. Primary endpoint was OS. A key secondary endpoint was objective response rate (ORR). Results: The Table shows OS and ORR by key baseline factors. Median follow-up was 17-18 mo. 77% and 23% of patients received 1 or 2 prior anti-angiogenic therapies, respectively, for advanced RCC, mainly sunitinib (63%) or pazopanib (32%). In patients who had prior sunitinib, median OS was 23.6 mo for NIVO vs 19.8 mo for EVE; in those who had prior pazopanib, median OS was not estimable (NE) for NIVO vs 17.6 mo for EVE. For those who had prior IL-2 (10%), median OS was NE for NIVO vs 17.2 mo for EVE. Outcomes by subsequent anticancer therapy are planned. Conclusions: A consistent OS benefit with NIVO vs EVE was found across baseline factors (Karnofsky performance status [KPS], Heng risk group, number of prior therapies), and specific prior therapies (sunitinib, pazopanib, IL-2) in previously treated patients with advanced RCC. ORR benefit with NIVO was also seen across baseline factors. Clinical trial information: NCT01668784

Case report form data.

NMedian OS,
mo (95% CI)
ORR, %
(95% CI)
KPS, %
    90–100540NE (26.7–NE)29.0 (24.3–NE)26.1 (21.0–31.7)6.8 (4.1–10.6)
    <9028118.1 (14.3–22.2)10.1 (7.9–12.8)23.1 (16.3–31.2)2.7 (0.7–6.8)
Heng risk group
    Favorable125NE29.0 (24.7–NE)23.6 (13.2–37.0)7.1 (2.4–15.9)
    Intermediate483NE (21.4–NE)19.9 (17.7–26.2)24.4 (19.1–30.3)5.0 (2.6–8.5)
    Poor17915.3 (10.6–20.4)8.4 (5.9–11.4)30.2 (21.3–40.4)4.8 (1.3–11.9)
Prior anti-angiogenic
    162923.6 (20.8–NE)19.9 (17.7–24.7)24.3 (19.7–29.4)5.4 (3.2–8.6)
    2189NE (18.1–NE)18.4 (14.0–NE)27.8 (18.9–38.2)5.1 (1.7–11.4)