| Description |
Subjects with advanced HCC represent a great unmet need. The clinical activity of nivolumab to date in subjects who were both sorafenib-naive and sorafenib treated suggests the potential to improve clinical outcomes in a first line setting. The preliminary safety profile also supports the tolerability of nivolumab in advanced HCC subjects. However, the potential benefit of nivolumab monotherapy over sorafenib is not yet established. Sorafenib was approved for HCC on the basis of 2 trials in a first line setting. Sorafenib has a safety profile characterized by diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia. Nivolumab has a different safety profile characterized by liver toxicity pneumonitis, diarrhea, and endocrinopathies, which are mostly low grade and manageable with the use of corticosteroids. In addition, while sorafenib is the only approved systemic therapy for HCC, it has a relatively low RR in the setting of a safety profile that requires relatively frequent dose reductions and drug discontinuation. Based on preliminary observations, nivolumab's risk benefit profile appears to favor nivolumab and warrants further investigation. In order to assess the potential benefit and safety of nivolumab monotherapy over standard-of-care sorafenib, a randomized trial comparing nivolumab monotherapy to sorafenib will be conducted. |
