Hepatocellular Carcinoma Update, Issue 1, 2017 (Video Program)Results of the placebo-controlled Phase III RESORCE trial evaluating the role of regorafenib for patients with HCC and disease progression after treatment with sorafenib
2:06 minutes.
TRANSCRIPTION:
DR EL-KHOUEIRY: I mentioned earlier the multiple failed trials until we got to regorafenib, which is really very similar to sorafenib, as far as the targets, but it’s a bit more broad. So there are certain targets of regorafenib that are not clearly targets of sorafenib. For example, FGFR, TIE2 — T-I-E-2. And the pharmacokinetics of regorafenib — of the byproducts of regorafenib — are different than sorafenib. The regorafenib RESORCE trial evaluated regorafenib in patients who had confirmed radiologic progression on sorafenib. And they were randomized in a 2-to-1 fashion against best supportive care and placebo. Patients must have tolerated sorafenib for 20 out of the last 28 days of therapy. And they must have tolerated a minimum dose of 400 mg daily. So it was a select patient population in that sense. The regorafenib trial, the RESORCE trial, showed a statistically significant improvement in survival. We’re talking about a median survival in the 10- to 11-month range compared to 7- to 8-month with placebo in second-line therapy. The other important observation from the RESOURCE trial is the fact that we were able to treat patients with hepatocellular carcinoma with regorafenib. Fifty percent of the patients actually were able to tolerate a full dose. About 50% had dose interruptions and reductions. This was an important observation. DR LOVE: This was 160 mg? DR EL-KHOUEIRY: The full dose? DR LOVE: Yes. Was 160 the same? DR EL-KHOUEIRY: 160, yes. DR LOVE: That's interesting. DR EL-KHOUEIRY: Now it’s important, again, to remember that these were patients with Child-Pugh A cirrhosis. These did not have decompensated cirrhosis. And they are patients, again, who had established sorafenib tolerability. That was part of the inclusion criteria. |