Josep Tabernero, MD, PhD, discusses findings from the phase 3 SUNLIGHT trial investigating the combination of bevacizumab plus trifluridine/tipiracil vs TAS-102 alone in patients with refractory metastatic colorectal cancer.
Josep Tabernero, MD, PhD, head of the Medical Oncology Department, the Vall d'Hebron University Hospital, director, the Vall d'Hebron Institute of Oncology (VHIO), discusses findings from the phase 3 SUNLIGHT trial (NCT04737187) investigating the combination of bevacizumab (Avastin) plus trifluridine/tipiracil (TAS-102; Lonsurf) vs TAS-102 alone in patients with refractory metastatic colorectal cancer (mCRC).
Data presented at the 2023 Gastrointestinal Cancers Symposium showed that the study met its primary end point with a statistically significant and a clinically meaningful improvement in overall survival (OS). Patients treated with bevacizumab/TAS-102 experienced a median OS of 10.8 months, compared with 7.5 months for patients treated with TAS-102 alone, representing a 39% reduction in the risk of death (HR, 0.61; 95% CI, 0.49-0.77; P < .001).
Additional study end points, including progression-free survival (PFS), time to deterioration in global-health status, and time to deterioration of ECOG performance status to 2 or higher, also favored bevacizumab/TAS-102, Tabernero explains. Notably, there was a statistically significant improvement in PFS, with bevacizumab/TAS-102 eliciting a median PFS of 5.6 months, compared with 2.4 months for TAS-102 alone (HR, 0.44; 95% CI, 0.36-0.54; P < .001).
The emergence of novel first- and second-line therapies for patients with mCRC has led to an increase in patients in the refractory setting, according to Tabernero, who notes that new combinations could help address unmet needs for patients with refractory mCRC.
SUNLIGHT enrolled 492 patients with refractory mCRC following 2 chemotherapy regimens. They were randomly assigned in a 1:1 fashion to receive bevacizumab plus TAS-102 or TAS-102 monotherapy.
Regarding safety, severe adverse effects (AEs) of grade 3 or higher occurred in 72.4% of patients in the bevacizumab/TAS-102 arm, compared with 69.5% in the TAS-102 arm. The most frequent severe treatment-emergent AEs for bevacizumab/TAS-102 and TAS-102 alone were neutropenia (43.1% and 32.1%, respectively) and anemia (6.1% and 11.0%).
Based on this data, bevacizumab plus TAS-102 may be another standard of care for patients with refractory mCRC, Tabernero concludes.