PHASE 3 CORRECT TRIAL OF REGORAFENIB IN METASTATIC COLORECTAL CANCER (MCRC)

ABSTRACT Introduction Regorafenib (REG) is an oral multi-kinase inhibitor. The CORRECT trial was conducted to evaluate REG in patients (pts) with mCRC who had progressed after all approved standard therapies. Methods Enrollment criteria included documented mCRC and progression during or ≤3 months after last standard therapy. Pts were randomized 2:1 to receive best supportive care plus either REG (160 mg od po, 3 wks on/1 wk off) or placebo (PL). The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), overall response rate, disease control rate, safety and quality of life (QoL). Efficacy analyses across prespecified subgroups were evaluated using univariate Cox regression. Mutations in KRAS, BRAF and PIK3CA genes were determined both from plasma DNA and from available biopsy samples using BEAMing technology. Historical KRAS status was collected from patient record. Results 760 pts were randomized (REG: 505; PL: 255). The OS primary endpoint was met at a preplanned interim analysis. OS and PFS were significantly improved in REG arm compared to PL arm. Hazard ratio (HR) for OS was 0.77 (95% CI 0.64-0.94, 1-sided p = 0.0052); median OS 6.4 vs 5.0 mos. HR for PFS was 0.49 (95% CI 0.42-0.58, 1-sided p Conclusion REG demonstrated statistically significant improvement in OS and PFS over PL, as well as comparable efficacy benefits across pt subgroups analyzed. Table 1 .