Outcomes of first-line (1L) immuno-oncology (IO) combination therapies in metastatic renal cell carcinoma (mRCC): Results from the International mRCC Database Consortium (IMDC).

Using the IMDC dataset, patients treated with a 1L and inhibitor combination (IOVE) were compared with those treated with Ipilimumab and nivolumab (IPI-NIVO). The outcomes of interest were overall response rate (ORR), treatment duration (TD), time to next treatment (TTNT), and overall survival (OS). A preplanned subgroup analysis of the IMDC intermediate/poor risk population was conducted. Hazard ratios were adjusted for IMDC risk factors.

More than 700 patients were included for analysis. The proportion of patients with IMDC favorable, intermediate, and poor risk disease in IPI-NIVO versus IOVE groups were 9% versus 33%, 58% versus 53%, 33% versus 14%, respectively. In the intermediate/poor risk groups, ORR and median TD were lower and shorter in IPI-NIVO versus IOVE while no difference in median TTNT and OS was detected. The HR for death adjusting for IMDC criteria for IPI-NIVO vs. IOVE was 0.92. IMDC risk groups and the presence or absence of sarcomatoid histology, brain, liver, or bone metastases were not associated with differences in OS between these treatments. Patients that had dose delays or steroid use for immune related adverse events (irAEs) were associated with longer median TTNT and OS despite similar treatment durations compared to those without dose delays or steroid use.

“We were unable to detect any differences in OS between IPI-NIVO and IOVE regimens in the IMDC intermediate/poor risk groups and amongst various subgroups. Patients who experienced irAEs requiring dose delay or steroids had longer overall survival,” write the authors.