Dr. Ghassan Abou-Alfa on Impact of Second-Line Regorafenib in HCC

Ghassan K. Abou-Alfa, MD, medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the impact of the phase III RESORCE trial, which demonstrated that regorafenib improved survival over placebo for patients with hepatocellular carcinoma (HCC) that progressed on sorafenib.

In the trial, the median overall survival (OS) was 10.6 months with regorafenib plus best supportive care compared with 7.8 months for placebo plus best supportive care. This represented a 37% reduction in the risk of death (HR 0.63; 95% CI 0.50-0.79; p<0.001).

Median progression-free survival was 3.1 months in the regorafenib arm compared with 1.5 months in the placebo group, representing a 54% reduction in the risk of progression or death (HR, 0.46; 95% CI, 0.37-0.56; P <.001). The median time to progression in the regorafenib group was 3.2 versus 1.5 months with placebo (HR, 0.44; 95% CI, 0.036-0.55; P <.001).

These data are unprecedented in second-line HCC, says Abou-Alfa. There have been many clinical trials with other novel agents that did not show any improvement in outcome in this setting.

Regorafenib, on a direct look, seems very similar to sorafenib, but based on these data, it is likely that it does differ in someway, he says. This will have to be evaluated further.

An additional piece of data regarding regorafenib was presented at the International Liver Cancer Association in Vancouver in Sept. This demonstrated that the combined survival for patients on sorafenib followed by regorafenib was 24 months. This is a number that is unheard of in the advanced setting of HCC, Abou-Alfa

This was not a pre-planned analysis, and more data is needed regarding how long patients received each agent. However, these finding are extremely impressive, says Abou-Alfa.