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

Meredith M. Regan, Opeyemi A. Jegede, Charlene M. Mantia, Thomas Powles, Lillian Werner, Robert J. Motzer, Nizar M. Tannir, Chung Han Lee, Yoshihiko Tomita, Martin H. Voss, Elizabeth R. Plimack, Toni K. Choueiri, Brian I. Rini, Hans J. Hammers, Bernard Escudier, Laurence Albiges, Stephen Huo, Viviana Del Tejo, Brian Stwalley, Michael B. AtkinsDavid F. McDermott

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

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-naive, 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. 3.7months).MeanTFSwith 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. 0.3months 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.

Original languageEnglish (US)
Pages (from-to)6687-6695
Number of pages9
JournalClinical Cancer Research
Volume27
Issue number24
DOIs
StatePublished - Dec 15 2021

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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