The phase 3 SUNLIGHT trial demonstrated that bevacizumab plus trifluridine/tipiracil (FTD/TPI) significantly improved overall survival (OS) and progression-free survival (PFS) compared with FTD/TPI as a single agent in patients with refractory metastatic colorectal cancer (mCRC).

The SUNLIGHT study was designed to evaluate the efficacy and safety of the addition of bevacizumab to FTD/TPI compared with FTD/TPI alone in patients with refractory mCRC.1 For this purpose, 492 patients who had received two prior lines of therapy were randomized 1:1 to a bevacizumab arm or to a FTD/TPI only arm. The primary outcome was OS. Results were presented by Prof. Josep Tabernero (Val d’Hebron University Hospital and Institute of Oncology, Spain) at ASCO-GI 2023.

The primary endpoint was met, favoring the bevacizumab arm over the FTD/TPI-only arm (median OS, 10.8 months vs 7.5; HR, 0.61; P<0.001). The PFS was also significantly improved in the bevacizumab group compared with the control group (median PFS, 5.6 months vs 2.4; HR, 0.44; P<0.001). Furthermore, the time to deterioration in global health status was prolonged in the experimental arm (median time, 8.5 months vs 4.7; HR, 0.50; P<0.001). The safety profiles of the two treatment regimens were comparable. Severe adverse events (AEs) were reported in 72% and 70% of patients in the respective study groups. Also, 13% in each group discontinued the study due to AEs.

“FTD/TPI plus bevacizumab improved the OS and PFS of patients with refractory mCRC compared with an active control, with a manageable safety profile,” said Prof. Tabernero. “Therefore, this regimen represents a novel standard of care for patients who have received 2 prior lines of therapy.”

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