4:12 PM Abstract No. 379 Updated overall survival (OS) analysis from the international, phase 3, randomized, placebo-controlled RESORCE trial of regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment

Abstract

The phase 3 RESORCE trial showed that regorafenib improved the primary endpoint of OS versus placebo in patients with unresectable HCC who progressed during sorafenib treatment. Secondary endpoints of progression-free survival, time to progression, disease control rate, and objective response rate were also improved with regorafenib (Bruix, et al. Lancet 2017). Adverse events were consistent with the known safety profile of regorafenib. We report updated OS results from RESORCE. Patients with Barcelona Clinic Liver Cancer stage B or C HCC with radiologic progression on sorafenib, Child–Pugh A liver function, and Eastern Cooperative Oncology Group performance status 0−1 were randomized 2:1 to regorafenib 160 mg/day or placebo for Weeks 1–3 of each 4-week cycle until progression, death, or unacceptable toxicity. The data cut-off for the primary analysis was February 29, 2016; the data cut-off for this updated OS analysis was January 23, 2017. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived using the Cox model. The updated HR for OS was similar to that of the primary OS analysis (Table). Estimated OS rates (regorafenib vs placebo) at 12, 18, and 30 months were 47% versus 28%, 32% versus 16%, and 16% versus 7%, respectively. Results for OS favored regorafenib in all preplanned subgroup analyses. The results of this updated OS analysis with a longer follow-up from the RESORCE trial confirm the results of the primary OS analysis, showing that regorafenib is an effective treatment option for patients with HCC who progress on prior sorafenib treatment.Tabled 1OSPrimary AnalysisUpdated AnalysisRegorafenib (n = 379)Placebo (n = 194)Regorafenib (n = 379)Placebo (n = 194)Patients with event, n (%)233 (61)140 (72)290 (77)169 (87)Median OS (95% CI), months10.6 (9.1, 12.1)7.8 (6.3, 8.8)10.7 (9.1, 12.2)7.9 (6.4, 9.0)HR (95% CI); 1-sided P value0.62 (0.50, 0.78); <0.00010.61 (0.50, 0.75); <0.0001 Open table in a new tab