500OCONCUR: A RANDOMIZED, PLACEBO-CONTROLLED PHASE 3 STUDY OF REGORAFENIB (REG) MONOTHERAPY IN ASIAN PATIENTS WITH PREVIOUSLY TREATED METASTATIC COLORECTAL CANCER (MCRC)

ABSTRACT Aim: Regorafenib, an oral multi-kinase inhibitor, improves overall survival (OS) in patients with mCRC who progressed after standard therapies. CONCUR (NCT01584830) was designed to evaluate the efficacy and safety of REG in Asian patients with mCRC. Methods: Patients with mCRC who progressed Results: Demographics and baseline characteristics were balanced in patients randomized to REG (n = 136) or placebo (n = 68). The median age was 57 yrs, all were ECOG PS 0–1, 53% had received >3 treatments for CRC, and 41% had no prior anti-VEGF or anti-EGFR therapy. Treatment with REG resulted in a 45% reduction in the risk of death (median OS 8.8 vs 6.3 months; one-sided p = 0.0002; Table), and improved PFS (HR 0.311; 95%CI 0.222–0.435; one-sided p Subgroups by prior targeted therapy N HR (95% CI) All patients 204 0.550 (0.395–0.765) No targeted therapy 84 0.359 (0.215–0.601) Anti-VEGF, or anti-EGFR, or both 120 0.747 (0.488–1.145) Anti-VEGF only 45 0.987 (0.482–2.025) Anti-EGFR only 39 0.719 (0.340–1.523) Both anti-VEGF and anti-EGFR 36 0.484 (0.217–1.081) Conclusions: Regorafenib provides a statistically significant improvement in OS in Asian patients with mCRC who progressed after standard therapies. Adverse events are consistent with the known safety profile of REG. Disclosure: T.W. Kim: Member of Pharma Advisory Boards for Merck and Abbvie. Received research funding from Bayer; T.C.C. Yau: Advisory Board member for Bayer; B. Ma: Advisory Board member for Bayer. Received research funding from Novartis, and Merck Serono; J. Shapiro: Employee of Sponsor (Bayer Pharma AG) J. Kalmus: Employee of Sponsor (Bayer Pharma AG); J. Li: Advisory Board member for Roche and Merck. Received research funding from Merck and Amgen. All other authors have declared no conflicts of interest.