Hepatocellular Carcinoma Update, Issue 1, 2017 (Video Program)Activity and tolerability of lenvatinib for unresectable HCC
3:46 minutes.
TRANSCRIPTION:
DR LOVE: So what about lenvatinib? It’s been really exciting in thyroid cancer. And now we’re starting to see some data in renal cell. How about in HCC? DR LLOVET: Well, it’s a very intriguing drug, I have to say, because the Phase II trial — I’m showing here the results. The authors report a 14-month median survival with 30% partial response. And this is completely unprecedented in HCC. There is no drug that can achieve 30% partial response. We are certainly intrigued about what’s going on with this drug. In HCC we have the RECIST and the modified RECIST. With the modified RECIST, for instance, with sorafenib, you can achieve 10%-15% objective responses. And beyond that it’s very difficult to get any drug. So for instance, we know — and I will show that later on — with nivo we are achieving 16% responses. But with lenvatinib — with few patients, though, they reported 30% objective responses. Median survival 14 months. The adverse events, listed here, are much more important than the ones observed with sorafenib. But the truth of the fact is that in the Phase III with 940 patients, they completed recruitment in June 2015 and still they have not reported the final results. Either it may so happen that the drug is very effective and that the events are not coming, which may be one situation. Or the other, that I’m mentioning below, is that they specifically exclude the patients with portal vein invasion that are the ones with the poorest prognosis in advanced. Eventually, for these patients the natural history will not be 8 months but maybe 11 months without treatment. And then you may be moving to 14, 15 months with treatment, if the trial is positive. Anyhow, I think that with this drug there are signs of potential efficacy. DR LOVE: And in terms of tolerability of lenvatinib, what do you see in terms of hand-foot, hypertension, et cetera? DR LLOVET: As I said, the figures are more important than sorafenib, but at least in the cases that we had in Sinai, certainly the adverse events were, if I have to say, less prominent than expected. We thought that this was a very toxic drug. And certainly the adverse events were manageable. DR LOVE: I was trying to remember from what I’ve heard in thyroid and renal. I don’t know that I remember hearing a lot about hand-foot, and yet here it looks like there was a lot of hand-foot. DR LLOVET: Yes. That’s right. But this includes all grades. It’s not Grade 3/4. DR LOVE: Oh, I see. Okay. DR LLOVET: It’s all grades only. So sometimes Grade 1 — I mean you have a lot of things there. DR LOVE: So for example, at this point, in your mind, from a quality-of-life point of view, particularly as it relates to hand-foot, do you think lenvatinib is going to be better tolerated than, for example, sorafenib? DR LLOVET: Better tolerated? No. DR LOVE: Worse. DR LLOVET: Worse tolerated. I think it’s a very potent drug. And it’s slightly more toxic than sorafenib. It’s more toxic than sorafenib. DR LOVE: Of course the big story in a lot of cancers nowadays is checkpoint inhibitors. And HCC has entered that arena now. |