Second-Line Therapy Options for mHCC

Transcript: Ghassan K. Abou-Alfa, MD: No doubt that both drugs are available. They’re both FDA approved. I agree with Farshid on the point that he noted that the response rates are rather intriguing to us. And yes, we are seeing patients with an incredible response on the lenvatinib per se. With this said, however, now that we have 2 drugs, we are not done yet with sorafenib because we’re going to move swiftly to second-line therapy. Second-line therapy, we never even mentioned the word when we talked about HCC [hepatocellular carcinoma], and now we have second-line therapy. Amit, let me ask you this. We hear about regorafenib in second-line after failure from sorafenib. Tell us more.

Amit Singal, MD: The RESORCE trial basically took patients who had tolerated sorafenib but had radiographic progression and then randomized them to receive regorafenib or placebo. In short, the RESORCE trial showed that those patients who were on regorafenib actually had significantly better survival. And oddly enough, the survival, it’s essentially very similar numbers to what you saw in the SHARP trial in terms of the hazard ratio as well as the survival differences. So once again, as you said, it brings in a new era where we start to think of not only first-line options but also options for patients after they progress on first-line therapy.

Ghassan K. Abou-Alfa, MD: Katie, regorafenib, which if anything, is known to our colleagues also in the colorectal cancer world. I would say the colorectal group was not super excited about it at some point. But at the same time, the data are the data. So tell us a little bit, would you see value for that drug? Would you use it?

Katie Kelley, MD: Absolutely. I think the data from the RESORCE trial are very strong and do emphasize that patients who did well on sorafenib and particularly well from a toxicity perspective, with tolerability of at least a 400 mg per day dose for greater than or equal to 20 of the preceding 28 days prior to start, have a clear-cut survival benefit on regorafenib and are able to tolerate the drug, which stands to reason because it’s very similar to sorafenib. So when thinking about this new realm of second-line therapy, one of the first questions I ask is what did they receive in first-line and how did they tolerate it? Regorafenib I think has its place for people who did receive first-line sorafenib and did very well on it from a toxicity tolerability perspective. I do like to see somebody, this is clinical anecdote, but perhaps who had benefit, progression-free survival for a number of months prior to progression. This is aligned with its label, that population for regorafenib. I think a patient who did not do well on first-line sorafenib from either toxicity or rapid progression is less likely and certainly wouldn’t fall in the population that showed benefit in the RESORCE trial.

Transcript Edited for Clarity