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Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial

Purpose: Patients discontinuing immuno-oncology regimens may experience periods of disease control without need for ongoing anticancer therapy, but toxicity may persist. We describe treatment-free survival (TFS), with and without toxicity.


Patients and Methods: Data were analyzed from the randomized phase III CheckMate 214 trial of nivolumab plus ipilimumab (n = 550) versus sunitinib (n = 546) for treatment-naïve, advanced renal cell carcinoma (aRCC). TFS was estimated by the 42-month restricted mean times defined by the area between Kaplan–Meier curves for two time-to-event endpoints defined from randomization: time to protocol therapy cessation and time to subsequent systemic therapy initiation or death. TFS was subdivided as TFS with and without toxicity by counting days with ≥1 grade ≥3 treatment-related adverse event (TRAE).

Results: At 42 months since randomization, 52% of nivolumab plus ipilimumab and 39% of sunitinib intermediate/poor-risk patients were alive; 18% and 5% surviving treatment-free, respectively. Among favorable-risk patients, 70% and 73% of nivolumab plus ipilimumab and sunitinib patients were alive; 20% and 9% treatment-free. Over the 42-month period, mean TFS was over twice as long after nivolumab plus ipilimumab than sunitinib for intermediate/poor-risk (6.9 vs. 3.1 months) and three times as long for favorable-risk patients (11.0 vs. 3.7 months). Mean TFS with grade ≥3 TRAEs was a small proportion of time for both treatments (0.6 vs. 0.3 months after nivolumab plus ipilimumab vs. sunitinib for intermediate/poor-risk, and 0.9 vs. 0.3 months for favorable-risk patients).

Conclusions: Patients initiating first-line nivolumab plus ipilimumab for aRCC spent more survival time treatment-free without toxicity versus those on sunitinib, regardless of risk group.

Meredith M. Regan,1,2 Opeyemi A. Jegede,1 Charlene M. Mantia,2,3 Thomas Powles,4 Lillian Werner,1 Robert J. Motzer,5 Nizar M. Tannir,6 Chung-Han Lee,5 Yoshihiko Tomita,7 Martin H. Voss,5 Elizabeth R. Plimack,8 Toni K. Choueiri,2,3 Brian I. Rini,9 Hans J. Hammers,10 Bernard Escudier,11 Laurence Albiges,11 Stephen Huo,12 Viviana Del Tejo,13 Brian Stwalley,12 Michael B. Atkins14 and David F. McDermott,2,15

  1. Division of Biostatistics, Dana-Farber Cancer Institute, Boston, Massachusetts.
  2. Department of Medicine, Harvard Medical School, Boston, Massachusetts.
  3. Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
  4. Department of Genitourinary Oncology, Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, Queen Mary University of London, Royal Free National Health Service Trust, London, United Kingdom.
  5. Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
  6. Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas.
  7. Department of Urology, Niigata University, Niigata, Japan.
  8. Division of Genitourinary Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
  9. Vanderbilt Ingram Cancer Center, Nashville, Tennessee.
  10. Division of Hematology and Oncology, UT Southwestern, Dallas, Texas.
  11. Department of Medical Oncology, Gustave Roussy, Villejuif, France.
  12. Worldwide Health Economics and Outcomes Research–US Market, Bristol Myers Squibb, Princeton, New Jersey.
  13. US Medical Oncology, Bristol Myers Squibb, Princeton, New Jersey.
  14. Division of Hematology/Oncology, Georgetown-Lombardi Comprehensive Cancer Center, Washington, District of Columbia.
  15. Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, Massachusetts.

Source: Regan M., Jegede O., Mantia C., et al. "Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial." Clin Cancer Res. 2021. DOI: 10.1158/1078-0432.CCR-21-2283.