In a poster presentation at this year’s European Society of Medical Oncology (ESMO) 2020 Virtual Annual Meeting, Dr. Laurence Albiges presented long-term data of the CheckMate214 trial comparing nivolumab and ipilimumab to sunitinib, with a focus on the subgroup of patients without a history of prior nephrectomy.
To briefly summarize the design of CheckMate 214, patients with advanced clear cell renal cell carcinoma were randomized in a 1:1 fashion to nivolumab 3mg/kg and ipilimumab 1mg/kg x 4 cycles followed by nivolumab or to sunitinib 50mg PO daily on a 4 week on / 2 week off schedule.
Primary outcomes measures include Overall Survival (OS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC), Investigator-assessed Objective Response Rate(ORR) in Intermediate/Poor Risk Participants as well as, Progression-Free Survival (PFS) in Intermediate/Poor-Risk Participants With Previously Untreated Metastatic Renal Cell Carcinoma (mRCC).This data presented at ESMO represented an updated analysis of patients with at least 4 years of follow-up. In the intention-to-treat population, the combined nivolumab/ipilimumab approach continued to demonstrate superiority (hazard ratio 0.69, 95% confidence interval 0.59 to 0.81). In sub-groups defined according to IMDC criteria, those with intermediate or poor-risk had improved survival with nivolumab/ipilimumab (hazard ratio 0.65, 95% confidence interval 0.54 to 0.78) while there was no appreciable difference among those with favorable-risk disease (hazard ratio 0.93, 95% confidence interval 0.62 to 1.40). Similar benefits in objective response rate were also seen.
The authors then presented post hoc analyses of patients without a history of nephrectomy for whom a target kidney lesion could be identified. Primary tumor responses were more common among patients receiving nivolumab/ipilimumab. Notably, no complete responses were seen.
Among patients with a target kidney lesion, median overall survival was longer among those randomized to nivolumab/ipilimumab (26.1 months, 95% confidence interval 13.9 to 35.4) as compared to sunitinib (14.3 months, 95% confidence interval 9.7 to 22.6) (hazard ratio 0.63, 95% confidence interval 0.40 to 1.00).
Presented by: Laurence Albiges, MD, Ph.D., Medical Oncologist, Department of Cancer Medicine, Institut Gustave Roussy
Written by: Christopher J.D. Wallis, Urologic Oncology Fellow, Vanderbilt University Medical Center (@WallisCJD on Twitter) at the European Society for Medical Oncology Virtual Congress, ESMO Virtual Congress 2020 #ESMO20, 18 Sept - 21 Sept 2020