SUNLIGHT trial meets primary endpoint in refractory metastatic CRC

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), representing a novel standard-of-care for patients who had received 2 prior lines of therapy.

The SUNLIGHT study (NCT04737187) 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 2 prior lines of therapy were randomised 1:1 to the bevacizumab arm or to the FTD/TPI only arm. In both arms, 72% of the patients had prior treatment with bevacizumab. The primary outcome was OS and the results were presented by Prof. Josep Tabernero (Val d’Hebron University Hospital and Institute of Oncology, Spain).

The primary endpoint was met, favouring the bevacizumab arm over the FTD/TPI-only arm (median OS 10.8 months vs 7.5 months; HR 0.61; 95% CI 0.49–0.77; P<0.001; see Figure). The PFS was also significantly improved in the bevacizumab group compared with the control group (median PFS 5.6 months vs 2.4 months; HR 0.44; 95% CI 0.36–0.54; 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 months; HR 0.50; 95% CI 0.38–0.65; P<0.001). The safety profiles of the 2 treatment regimens were comparable. Severe adverse events (AEs) were reported in 72% and 70% of the patients in the respective study groups. Also, 13% in each group discontinued the study due to AEs.

Figure: Overall survival higher in the bevacizumab arm versus the FTD/TPI-only arm [1]

FTD/TPI, bevacizumab plus trifluridine/tipiracil.

“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 new standard of care for patients who have received 2 prior lines of therapy.”

1. Tabernero J, et al. Trifluridine/tipiracil plus bevacizumab for third-line treatment of refractory metastatic colorectal cancer: The phase 3 randomized SUNLIGHT study. Abstract 4, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.

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Posted on 17 March, 2023