NIVOLUMAB PLUS low-dose ipilimumab continued to demonstrate strong responses as well as a survival benefit with a median of 32.4 months of follow-up as front-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, according to an update of the phase II CheckMate 214 trial.1
OF NOTE
Based on the primary CheckMate 214 data analysis, the U.S. Food and Drug Administration approved the combination of nivolumab and ipilimumab in April 2018 as front-line treatment for intermediate- and poor-risk patients with advanced renal cell carcinoma. The updated analysis confirms the primary analysis.The overall survival rate at 30 months was 60% with the immunotherapy combination vs 47% with sunitinib in the intermediate- and poor-risk population (P < .0001). The objective response rates were 42% vs 29% (P = .0001), respectively, including complete response rates of 11% with the nivolumab/ipilimumab combination vs 1% with sunitinib. Among responders, 52% of patients receiving nivolumab/ ipilimumab had a duration of response of 18 months or longer vs 28% of patients on the sunitinib arm.
In an intent-to-treat analysis of all 1,096 randomized patients, the 30-month overall survival rate was 64% with the immunotherapy combination vs 56% with sunitinib (P = .0003). The objective response rates in the intent-to- treat population was 41% vs 34% (P = .015), respectively, including complete response rates of 11% vs 2%.
No new safety signals for the combination emerged with long-term follow-up. Adverse events were consistent with previous reports for these agents in patients with renal cell carcinoma.
Nizar M. Tannir, MD
“The results from this 30-month follow-up from the CheckMate 214 study are meaningful as they continue to demonstrate that in patients with advanced renal cell carcinoma, a population with considerable unmet treatment needs, there is potential for long-term survival benefits with the combination of nivolumab and ipilimumab,” stated lead author Nizar M. Tannir, MD, Professor and Deputy Department Chair in the Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston.
The open-label CheckMate 214 trial showed an overall survival advantage with nivolumab plus ipilimumab vs sunitinib in patients with previously untreated advanced renal cell carcinoma.
The primary analysis found that the nivolumab/ipilimumab combination demonstrated a 37% reduction in the risk of death vs sunitinib in intermediate- and poor-risk patients with advanced renal cell carcinoma, regardless of programmed cell death ligand 1 expression status (P <. 0001). Median overall survival was not yet reached for the combination vs 25.9 months for sunitinib. ■
DISCLOSURE: Dr. Tannir has received honoraria from Bristol-Myers Squibb, Calithera Biosciences, Exelixis, Nektar, Novartis, and Pfizer; is a consultant/advisor with Bristol-Myers Squibb, Exelixis, Nektar, Novartis, and Pfizer; has received research funding from Bristol-Myers Squibb, Exelixis, and Novartis; has received travel/accommodations/expenses from Bristol-Myers Squibb, Calithera Biosciences, Nektar, and Pfizer; and has other financial relationships with Eisai Medical Research, Epizyme, Mirati Therapeutics, Oncorena, and Ono Pharmaceutical.
REFERENCE
1. Tannir NM, ArОn Frontera, Hammers HJ, et al: Thirty-month follow-up of the phase III CheckMate 214 trial of first-line nivolumab + ipilimumab or sunitinib in patients with advanced renal cell carcinoma. 2019 Genitourinary Cancers Symposium. Abstract 547. Presented February 16, 2019.
