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Nivolumab Plus Ipilimumab in Advanced Kidney Cancer: CheckMate 214 Update

By: Celeste L. Dixon
Posted: Wednesday, November 6, 2019

Extended follow-up of patients in the 28-country phase III CheckMate 214 study revealed that nivolumab plus ipilimumab has maintained superior efficacy over sunitinib in intermediate-risk, poor-risk, and intention-to-treat patients with previously untreated advanced renal cell carcinoma with a clear cell component. Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues reported their work in The Lancet Oncology.

The manageable safety profile of nivolumab plus ipilimumab did not change since earlier reports, either, the team noted. CheckMate 214 initially involved 425 versus 422 intermediate- or poor-risk patients and 125 versus 124 favorable-risk patients in the nivolumab/ipilimumab and sunitinib arms, respectively (550 versus 546 total in the intention-to-treat population). The combination treatment was intravenous nivolumab plus ipilimumab every 3 weeks for four doses, followed by nivolumab every 2 weeks; oral sunitinib was taken once daily for 4 weeks followed by 2 treatment-free weeks, in 6-week cycles.

With a median follow-up of 32.4 months in the intermediate- and poor-risk patients, the combination was superior to sunitinib in overall survival (median not reached vs. 26.6 months; P < .0001), progression-free survival (median 8.2 vs. 8.3 months; P = .0014), and proportion achieving an objective response (178 of 425 vs. 124 of 422; P = .0001). In intention-to-treat patients, the combination showed improved efficacy compared with sunitinib in terms of overall survival (median not reached vs. 37.9 months; P = .0003), progression-free survival (median 9.7 vs. 9.7 months; P = .027), and proportion achieving an objective response (227 of 550 vs. 186 of 546; P = .015).

These results “support ongoing studies combining nivolumab plus ipilimumab with novel drugs,” noted Dr. Motzer and his team. In addition, “ongoing molecular and genomic analyses of CheckMate 214 and other studies might indicate predictive biomarkers of response or prognostic factors to nivolumab plus ipilimumab.”

Disclosure: For full disclosures of the study authors, visit thelancet.com.



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