ASCO GU 2019: Phase III CheckMate 214 Trial of First-Line Nivolumab + Ipilimumab or Sunitinib in Patients with Advanced Renal Cell Carcinoma with Thirty Month Follow Up Results

San Francisco, CA (UroToday.com) Checkmate 214 revolutionized front-line treatment of patients with intermediate or poor risk metastatic renal cell carcinoma (mRCC) by introducing combination immunotherapy ipilimumab and nivolumab.  In the original New England Journal of Medicine publication in 2018, at a median follow up of 25.2 months, the 18-month overall survival was 75% with ipi/nivo compared with 60% with sunitinib for patients with intermediate or poor risk features, and the objective response rate was 42% vs 27% (p<0.001) with an impressive 9% complete response rate,1 which led to FDA approval of ipi/nivo in April 2018 and EMA approval in 11/2018. This abstract provides an update to the original data with 30 month follow up results. 

In CheckMate 214, patients received Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg every three weeks for 4 cycles, followed by nivolumab 3 mg/kg every 2 weeks. Patients randomized to sunitinib received sunitinib 50 mg on a 4 week on, 2 week off regimen. At this 30-month update, the overall survival benefit of ipi/nivo remains over sunitinib for the intention to treat cohort as well as for patients with intermediate or high-risk mRCC. Median survival has not been reached, compared with 37.9 months for patients on sunitinib. At 30 months, overall survival was 64% in the ipi/nivo arm and 56% in the sunitinib arm.
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For patients with favorable risk disease, this updated data shows that there was no significant difference in median overall survival, both groups not yet reached, HR 1.22, p=0.4426.  For patients who had achieved a CR, 88% of patients in the intention to treat analysis continue to have a response. Even in patients with favorable risk, the CR was very durable and maintained in 9 of 10 patients.
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In terms of safety, 35% of patients on ipi/nivo required high dose steroids for immune-related treatment adverse events. 
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Since the publication of CheckMate 214, the combination of ipi/nivo has been rapidly adopted for intermediate and poor risk patients with mRCC. The data presented today also provides some evidence for utilizing ipi/nivo in good risk patients as well, because of increased number of complete responses compared with sunitinib, and the durability of those complete responses. At the end of the talk, based on this data, Dr. Tannir recommended that ipi/nivo may be used for all patients with mRCC, regardless of risk classification.
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Presented by: Nizar M. Tannir, MD, FACP, Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston

Written by: Jason Zhu, MD. Fellow, Division of Hematology and Oncology, Duke University, Twitter: @TheRealJasonZhu at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA

References:
  1. Motzer RJ, Tannir NM, McDermott DF, et al. Nivolumab plus ipilimumab versus sunitinib in advanced renal-cell carcinoma. New England Journal of Medicine 2018;378:1277-90.
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