Nivolumab plus Ipilimumab versus Sunitinib

Nivolumab plus ipilimumab was proven superior to sunitinib in objective response rate and overall survival in patients with advanced renal cell carcinoma (RCC) in the phase 3 CheckMate 214 trial. The trial included treatment-naïve patients with clear-cell, advanced RCC with International Metastatic RCC Database Consortium (IMDC) intermediate/poor risk.

During a poster session at the ASCO 2019 Annual Meeting, David F. McDermott, MD, and colleagues reported results of a post-hoc exploratory analyses of nivolumab plus ipilimumab versus sunitinib in CheckMate 214 RCC patients with sarcomatoid features (sRCC). To identify the presence of sarcomatoid features, the researchers performed a keyword search for sarcomatoid in patients with available pathology reports accompanying pretreatment tumor samples. Results of the analysis were reported in a poster titled CheckMate 214 Post-Hoc Analyses of Nivolumab plus Ipilimumab or Sunitinib in IMDC Intermediate/Poor-risk Patients with Previously Untreated Advanced Renal Cell Carcinoma with Sarcomatoid Features.

Of 1096 intention-to-treat patients, 77% (n=842) had local pathology reports available, including 112 randomized patients with intermediate/poor risk scores (N plus I, n=60; S, n=52). Baseline characteristics of sRCC patients were balanced between the two arms. At baseline, 47% of intermediate/poor risk sRCC patients in the nivolumab plus ipilimumab arm and 53% of intermediate/poor risk sRCC patients in the sunitinib arm had tumor PD-L1 expression ≥1%, compared with 26% and 29% of all intermediate/poor risk patients, respectively.

Descriptive analyses were performed at a minimum follow-up of 30 months. Results confirmed that nivolumab plus ipilimumab improved overall response rate and complete response rate per investigator (Response Evaluation Criteria in Solid Tumors, version 1.1), overall survival, and progression-free survival per investigator compared with sunitinib in intermediate/poor risk patients with sRCC. There were no new safety signals seen in sRCC patients.

In conclusion, the researchers said, “In this post hoc descriptive subgroup analysis of CheckMate 214, nivolumab plus ipilimumab demonstrated promising efficacy and prolonged survival versus sunitinib, with consistent safety, in previously untreated intermediate/poor risk, advanced clear-cell RCC with sarcomatoid features. Prospective studies of nivolumab plus ipilimumab that include patients with sRCC are ongoing.”

Clinical trial information: NCT02231749

Source: McDermott DF, Choueiri TK, Motzer R. et al. CheckMate 214 post-hoc analyses of nivolumab plus ipilimumab or sunitinib in IMDC intermediate/poor risk patients with previously untreated advanced renal cell carcinoma with sarcomatoid features. Abstract of a poster presented at the American Society of Clinical Oncology 2019 Annual Meeting, June 3, 2019, Chicago, Illinois.