Stivarga for HCC – pro
There is a great deal of interest in regorefanib for HCC,and the evidence is beginning to emerge. An open-label phase II study (Bolondi et al) suggested that REG, a multikinase inhibitor, had an acceptable safety profile and showed evidence of antitumor activity in patients with progressive HCC and disease control was achieved in 26/36 patients (72%) and median time to progression (TTP) was 4.3 months; median overall survival (OS) was 13.8 months. Bruix evaluated 36 patients and concluded that regorafenib had acceptable tolerability and evidence of antitumour activity in patients with intermediate or advanced HCC that progressed following first-line sorafenib. A phase III Resource trial presented in 2016 by Jordi Bruix, MD, et al during the European Society of Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer in Barcelona,1 found that patients taking regorafenib had a median overall survival of 10.6 months vs 7.8 months for placebo plus best supportive care (hazard ratio [HR], 0.62; 95% confidence interval[CI], 0.50–0.78; P < .001).
According to findings from the phase 3 RESORCE trial, patients with unresectable hepatocellular carcinoma (HCC) who received Stivarga (regorafenib) had an improved overall survival (OS) rate when compared with the best supportive care, Nexavar (sorafenib). Bayer had applied for an FDA indication for this drug gor HCC.
Bruix J et al, Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: multicentre, open-label, phase II safety study.Eur J Cancer. 2013 Nov;49(16):3412-9.
Bruix J, Merle P, Granito A, et al. Efficacy and safety of regorafenib versus placebo in patients with hepatocellular carcinoma (HCC) progressing on sorafenib: results of the international, randomized phase 3 RESORCE trial. Presented at: 2016 World Congress on GI Cancer; June 28 – July 2, 2016; Barcelona, Spain. Abstract LBA03. – See more at: http://www.onclive.com/web-exclusives/fda-approval-sought-for-regorafenib-in-advanced-liver-cancer#sthash.9oCluXz8.dpuf
Bruix J, Merle P, Granito A, et al: Efficacy and safety of regorafenib versus placebo in patients with hepatocellular carcinoma progressing on sorafenib: Results of the international, randomized phase 3 RESORCE trial. ESMO World Congress on Gastrointestinal Cancer. Abstract LBA-03. Presented June 30, 2016.
Gong XL, Qin SK. Progress in systemic therapy of advanced hepatocellular carcinoma. World J Gastroenterol. 2016 Aug 7; 22(29):6582-94
A. Lii-Cheng et al, Regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing following sorafenib: An ongoing randomized, double-blind, phase III trial. J Clin Oncol 31, 2013 (suppl; abstr TPS4163)
Bolondi et al.Regarefanib for HCC, Eur J Cancer 2011; 47 [Suppl 1]: abstract 6.576