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FDA Grants Nivolumab/Ipilimumab Priority Review for RCC

Jason M. Broderick @jasoncology
Published: Thursday, Dec 14, 2017

Among all treated patients, with a median follow-up of 25.2 months, 77% of patients assigned to nivolumab plus ipilimumab and 82% assigned to sunitinib discontinued treatment. The main reason for discontinuation in each group was disease progression (42% in the combination immunotherapy group and 55% in the sunitinib group). The median duration of therapy was 7.9 and 7.8 months, respectively. In the immunotherapy arm, the median number of nivolumab doses received was 14 and the median number of ipilimumab doses received was 4. Seventy-four percent of patients received all 4 doses of ipilimumab.

Adverse events (AEs) leading to discontinuation occurred in 22% of patients in the combination immunotherapy group compared with 12% in the sunitinib group. The most common grade 3/4 AEs in the combination group were fatigue (4%) and diarrhea (4%). In the sunitinib group, the most common grade 3/4 AEs were hypertension (16%), fatigue (9%), and Palmar-plantar erythrodysesthesia syndrome (9%). There were 7 treatment-related deaths in the combination group and 4 in the sunitinib group.
Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: Efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naive advance or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. Presented at: 2017 ESMO Congress; Madrid, Spain; September 8-12, 2017. Abstract LBA5.



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