Hepatocellular Carcinoma Update, Issue 1, 2017 (Video Program)Phase III Study 304 comparing lenvatinib to sorafenib as first-line therapy for unresectable HCC
1:27 minutes.
TRANSCRIPTION:
DR EL-KHOUEIRY: This was a randomized Phase III trial of lenvatinib versus sorafenib in first-line therapy. It was designed as a noninferiority study with a primary endpoint of overall survival. And we are told that it met its primary endpoint. We are also told that there were some signs of superiority or improvement in some of the secondary endpoints, including response rate and time to progression. This, we are told, also will be presented soon, so I’m assuming at ASCO 2017 we’ll be hearing about this Phase III trial. DR LOVE: I don't know. It seems kind of strange that they would do a noninferiority trial. What was the thinking? DR EL-KHOUEIRY: Probably multiple considerations go into these decisions. DR LOVE: Is it significantly less toxic? DR EL-KHOUEIRY: From what we know about the drug, the toxicity profiles do overlap between the 2 drugs, except that there seems to be — based at least on the press release and some of the data in other tumor types, the skin toxicity may be a bit less with lenvatinib. We’ll see if that pans out when we hear all the data. DR LOVE: Have you yourself used lenvatinib in any patients with HCC? DR EL-KHOUEIRY: No, I have not. There was a previous Phase II trial done in this population, which was about 46 patients. And we had not participated in that study. |