Abstract CT085: A multi-cohort study of treatment regimens for metastatic colorectal cancer (mCRC): Subgroup analysis of sequential therapy between fruquintinib and regorafenib

Abstract Background: In the management of mCRC, the selection of optimal treatment regimens, particularly when considering sequential therapies, is crucial for improving patient outcomes. Fruquintinib (Fru) is a small-molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1/2/3 to inhibit the proliferation of vascular and lymphatic endothelial cells, thereby exerting its effects in suppressing tumor growth and metastasis. Regorafenib (Reg) exerts inhibitory effects on multiple targets including VEGFR-1/2/3, TIE-2, and CSF-1R. However, the optimal sequencing of these agents remains unclear. This study aims to compare the effectiveness of different sequential treatment approaches involving Fru and Reg. Methods: This study included mCRC patients (pts) who received sequential treatment regimens including both Fru and Reg. Pts were divided into two groups based on their treatment sequence: the Fru-Reg group (treated with Fru followed by Reg) and the Reg-Fru group (treated with Reg followed by Fru). In addition, a subgroup analysis was conducted based on the treatment regimen received before the sequential therapy, including monotherapy (mono) or combination therapy. The primary endpoint was median overall survival (mOS), and statistical analysis was performed by comparing the hazard ratio (HR) and P-value among the groups. Results: A total of 53 pts were included, with 35 pts in the Fru-Reg group and 18 pts in the Reg-Fru group. In the mono subgroup, there were 19 pts in the Fru-Reg (mono) group and 7 pts in the Reg-Fru (mono) group. In the total pts population, the mOS for the Fru-Reg (Total) group was 21.17 months compared to 19.12 months for the Reg-Fru (Total) group. Within the mono subgroup, the mOS for the Fru-Reg (mono) group was 19.05 months versus 15.79 months for the Reg-Fru (mono) group. Conclusion: This study provides valuable insights into the comparative effectiveness of sequential Fru and Reg treatment regimens in pts with mCRC. The results showed that in the overall patient population and mono subgroup, pts with Fru sequential Reg had a trend of benefit in mOS compared with pts with Reg sequential Fru opposite, but the difference was not statistically significant, we will continue to increase the sample size of the enrolled pts to further validate this finding. Citation Format: Wangxia Lv, Bixia Liu, Tingting Feng, Zhong Shi, Junchi Cheng, Haijun Zhong, Meiqin Yuan. A multi-cohort study of treatment regimens for metastatic colorectal cancer (mCRC): Subgroup analysis of sequential therapy between fruquintinib and regorafenib [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT085.