Bevacizumab Added to FTD-TPI in Third-Line Therapy for Metastatic Colorectal Cancer

Trifluridine-tipiracil (FTD-TPI) is an approved late-line therapy in chemotherapy-refractory metastatic colorectal cancer. Bevacizumab is combined with first- and second-line chemotherapy, but its continued use in later-line therapy has not been clearly supported in clinical trials. Investigators now report results of the SUNLIGHT trial, a global, open-label, industry-sponsored, randomized, phase 3 trial evaluating the use of standard-regimen FTD-TPI, given with or without bevacizumab (5 mg/kg) every 2 weeks, in chemotherapy-refractory colorectal cancer.

Of the 492 patients treated, 72% had left-sided primary tumors, 92% had received two prior chemotherapy regimens, 72% had received prior anti–vascular endothelial growth factor (VEGF) therapy, 20% received bevacizumab as part of first- and second-line chemotherapy, and of the 31% with RAS wild-type cancers, 94% had received prior epidermal growth factor (EGFR)–targeted therapy.

At a median follow-up of 14 months, the primary endpoint of median overall survival was significantly longer with the addition of bevacizumab (10.8 vs. 7.5 months; hazard ratio, 0.61). Overall survival at 6 months and at 12 months were also better with bevacizumab added (77% vs. 61% and 43% vs. 30%, respectively). Progression-free survival was significantly longer with bevacizumab (5.6 vs. 2.4 months; HR for disease progression or death, 0.44), and response rate was also better (6.1% vs. 1.2%). No new safety signals were observed; hypertension and neutropenia were more common with bevacizumab.