GU Symposium 2021: Updated CheckMate 9ER Results on Nivolumab Plus Cabozantinib in Kidney Cancer
Posted: Friday, February 26, 2021
At the 2021 Genitourinary (GU) Cancers Symposium, Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues presented their data on the efficacy of nivolumab plus cabozantinib versus sunitinib for previously untreated advanced renal cell carcinoma. During the Checkmate 9ER trial, this first-line therapy demonstrated improved efficacy and survival compared with sunitinib in these patients, regardless of sarcomatoid status (Abstract 308).
This phase III, open-label trial enrolled 651 adults with confirmed advanced renal cell carcinoma. The presence of signet renal cell carcinoma was detected in 11.5% of participants; the status of signet renal cell carcinoma was not reported in 19 patients. Patients were split into two groups (with or without signet status) and then randomly assigned 1:1 to receive either nivolumab plus cabozantinib or sunitinib.
At the median follow-up of 23.5 months, the nivolumab-plus-cabozantinib groups showed notable improvements in progression-free survival, overall survival, and overall response rate compared with those in the sunitinib groups, regardless of tumor PD-L1 expression. The combination doubled the median progression-free survival compared with sunitinib (17.0 months vs. 8.3 months). Nearly twice as many patients responded to nivolumab plus cabozantinib as to sunitinib (54.8% vs. 28.4%). Improvements in overall survival were also maintained with the combination therapy, with a 34% reduction in the risk of death compared with sunitinib. In addition to the outcomes benefits, the investigators reported significant quality-of-life improvements in these patients as well.
In an exploratory subgroup analysis of 75 patients with sarcomatoid features—a population typically with a poor prognosis—the combination showed a benefit, reducing the risk of death by 64% vs sunitinib; also in this subgroup, both superior progression-free survival (10.3 months vs. 4.2 months) and objective response rate (55.9% vs, 22.0%) were reported with the combination therapy.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.