Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
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BACKGROUND: Nivolumab, a programmed death 1 (PD-1) checkpoint inhibitor, was associated with encouraging overall survival in uncontrolled studies involving previously treated patients with advanced renal-cell carcinoma. This randomized, open-label, phase 3 study compared nivolumab with everolimus in patients with renal-cell carcinoma who had received previous treatment. METHODS: A total of 821 patients with advanced clear-cell renal-cell carcinoma for which they had received previous treatment with one or two regimens of antiangiogenic therapy were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10-mg everolimus tablet orally once daily. The primary end point was overall survival. The secondary end points included the objective response rate and safety. RESULTS: The median overall survival was 25.0 months (95% confidence interval [CI], 21.8 to not estimable) with nivolumab and 19.6 months (95% CI, 17.6 to 23.1) with everolimus. The hazard ratio for death with nivolumab versus everolimus was 0.73 (98.5% CI, 0.57 to 0.93; P=0.002), which met the prespecified criterion for superiority (P≤0.0148). The objective response rate was greater with nivolumab than with everolimus (25% vs. 5%; odds ratio, 5.98 [95% CI, 3.68 to 9.72]; P<0.001). The median progression-free survival was 4.6 months (95% CI, 3.7 to 5.4) with nivolumab and 4.4 months (95% CI, 3.7 to 5.5) with everolimus (hazard ratio, 0.88; 95% CI, 0.75 to 1.03; P=0.11). Grade 3 or 4 treatment-related adverse events occurred in 19% of the patients receiving nivolumab and in 37% of the patients receiving everolimus; the most common event with nivolumab was fatigue (in 2% of the patients), and the most common event with everolimus was anemia (in 8%). CONCLUSIONS: Among patients with previously treated advanced renal-cell carcinoma, overall survival was longer and fewer grade 3 or 4 adverse events occurred with nivolumab than with everolimus. (Funded by Bristol-Myers Squibb; CheckMate 025 ClinicalTrials.gov number, NCT01668784.).
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ICB, especially targeting PD-1 expressed on CD8+ T cells, is a highly effective immunotherapy for various cancers.
“Immune checkpoint blockade (ICB), especially targeting the inhibitory receptor programmed cell death 1 (PD-1) expressed on CD8+ T cells, is a highly effective immunotherapy for various cancers.”
From Contrasting cytotoxic and regulatory T cell responses underlying distinct clinical outcomes to anti-PD-1 plus lenvatinib therapy in cancer (2025) · cites this paper as [3]
The Introduction (page unavailable) identifies nivolumab as a PD-1 checkpoint inhibitor and says PD-1 is expressed on activated T cells; it does not specify CD8+ T cells. The Results > Efficacy section (page unavailable) reports improved survival and response versus everolimus in previously treated advanced renal-cell carcinoma. The Discussion mentions findings in melanoma and some lung cancers, but this trial does not establish that checkpoint blockade is highly effective across various cancers. (LLM, conf=0.87)
Experimental — accuracy not yet measuredPrimary resistance to immune checkpoint inhibitors is common in patients with both RCC and NSCLC, ranging from 35% to 44%, and remains unpredictable.
“Primary resistance to ICI is common in patients with both RCC and NSCLC, ranging from 35% to 44% and remains unpredictable [1,3].”
Response rates to ICIs range from 15-30% in most solid tumors to 45-60% in melanoma and MSI-H tumors.
“Response rates range from 15 to 30% (in most solid tumors) to 45–60% (in melanoma and MSI-H tumors).”
From Immune-related adverse events and anti-tumor efficacy of immune checkpoint inhibitors (2019) · cites this paper as [3]
Antibodies blocking PD-1 or PD-L1 have been approved to treat various solid and hematologic malignancies.
“At present, antibodies blocking PD-1 or its ligand PD-L1 have been approved to treat various solid and hematologic malignancies (Table 1) [7–12].”
From Combination strategies with PD-1/PD-L1 blockade: current advances and future directions (2022) · cites this paper as [8]
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Self-citation
- Authors
- Motzer, R. J., Escudier, B., McDermott, D. F., George, S., Hammers, H. J., Srinivas, S., Tykodi, S. S., Sosman, J. A., Procopio, G., Plimack, E. R., Castellano, D., Choueiri, T. K., Gurney, H., Donskov, F., Bono, P., Wagstaff, J., Gauler, T. C., Ueda, T., Tomita, Y., Schutz, F. A., Kollmannsberger, C., Larkin, J., Ravaud, A., Simon, J. S., Xu, L.-A., Waxman, I. M., & Sharma, P.
- Affiliations
- Brigham and Women's Hospital (US)
- Institut Gustave Roussy (FR)
- Beth Israel Deaconess Medical Center (US)
- Roswell Park Comprehensive Cancer Center (US)
- Sidney Kimmel Comprehensive Cancer Center (US)
- Stanford Cancer Institute (US)
- University of Washington (US)
- Vanderbilt University Medical Center (US)
- Fondazione IRCCS Istituto Nazionale dei Tumori (IT)
- Fox Chase Cancer Center (US)
- Hospital Universitario 12 De Octubre (ES)
- Westmead Hospital (AU)
- Aarhus University Hospital (DK)
- University of Helsinki (FI)
- Swansea University (GB)
- Essen University Hospital (DE)
- Chiba Cancer Center (JP)
- Niigata University (JP)
- Beneficência Portuguesa de São Paulo (BR)
- BC Cancer Agency (CA)
- Royal Marsden Hospital (GB)
- Centre Hospitalier Universitaire de Bordeaux (FR)
- Bristol-Myers Squibb (United States) (US)
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Motzer, Robert J.
- Escudier, Bernard
- McDermott, David F.
- George, Saby
- Hammers, Hans J.
- Tykodi, Scott S.
- Sosman, Jeffrey A.
- Procopio, Giuseppe
- Plimack, Elizabeth R.
- Castellano, Daniel
- Choueiri, Toni K.
- Gurney, Howard
- Donskov, Frede
- Bono, Petri
- Wagstaff, John
- Gauler, Thomas C.
- Ueda, Takeshi
- Tomita, Yoshihiko
- Schutz, Fabio A.
- Kollmannsberger, Christian
- Larkin, James
- Ravaud, Alain
- Sharma, Padmanee
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-11-05
- Volume
- 373
- Issue
- 19
- Pages
- 1803-1813
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC5719487
- OpenAlex
- W2222086386
- Cited by
- 5,807
- References
- 34
- Citations by year
- 2026: 173 · 2025: 255 · 2024: 367 · 2023: 449 · 2022: 535 · 2021: 669 · 2020: 723 · 2019: 669 · 2018: 719 · 2017: 691 · 2016: 511 · 2015: 36 · 2014: 4 · 2013: 1
- FWCI
- 515.99
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Ghent University Academic Bibliography (Ghent University) (submittedVersion, other-oa)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- Lirias (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- National Cancer Institute (P30CA008748)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Renal cell carcinoma treatment
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Ferroptosis and cancer prognosis
- Keywords
- nivolumab, everolimus, PD-1 inhibitors, mTOR inhibitors, overall survival, objective response rate, progression-free survival, treatment-related adverse events, anti-angiogenic therapy, immune checkpoint inhibitors, mTOR inhibition, fatigue, anemia, previously treated patients
- MeSH terms
- Everolimus, Nivolumab, Adolescent, Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Antineoplastic Agents, Carcinoma, Renal Cell, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Quality of Life, Survival Analysis, Sirolimus, Young Adult
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