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FDA Approves Nivolumab for Hepatocellular Carcinoma

Published: Friday, Sep 22, 2017

The FDA has granted an accelerated approval to nivolumab (Opdivo) for the treatment of patients with hepatocellular carcinoma (HCC) following prior sorafenib (Nexavar), regardless of PD-L1 status. 

In the sorafenib-naïve group across both the dose expansion and escalation cohorts (n = 80), the ORR by BICR was 20% by RECIST v1.1 and 24% by mRECIST. The v1.1 analysis noted 1 complete response (1%), 15 partial responses (19%), and 27 patients with stable disease (34%). Median duration of response was 17 months.


In the treatment expansion cohort, the median overall survival (OS) was 15.6 months (95% CI, 13.2-18.9). The 12-month OS rate was 60% and the 18-month rate was 44%. In the sorafenib-naïve group, the median OS was 28.6 months with nivolumab. The 12- and 18-month OS rates were 73% and 57%, respectively.

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