Bevacizumab plus trifluridine and tipiracil is a new standard of care for patients with refractory metastatic colorectal cancer (CRC), according to a presentation at the 2023 ASCO Gastrointestinal Cancers Symposium.
Adding bevacizumab to treatment with trifluridine and tipiracil improved progression-free survival (PFS) and overall survival (OS) in patients with refractory metastatic CRC in the phase 3 SUNLIGHT trial.
“The SUNLIGHT study actually is the first phase 3 study in the setting of refractory metastatic colorectal cancer to demonstrate an improvement in overall survival vs an active control,” said study presenter Josep Tabernero, MD, PhD, of Vall d’Hebron Hospital Campus and Institute of Oncology in Barcelona, Spain.
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The trial (ClinicalTrials.gov Identifier: NCT04737187) enrolled patients with metastatic CRC who had received 2 prior treatment regimens. Patients were randomly assigned to receive either trifluridine plus tipiracil (n=246) or trifluridine plus tipiracil and bevacizumab (n=246).
The median age at baseline was 62 years in the bevacizumab arm and 64 years in the control arm. Roughly half of patients were men (50% and 55%, respectively), most patients had RAS mutations (70% and 69%), and most had prior treatment with bevacizumab (72% in both arms).
The primary endpoint was OS. The median OS was 7.5 months in the control arm and 10.8 months in the bevacizumab arm (hazard ratio [HR], 0.61; 95% CI, 0.49-0.77; P <.001). The 6-month OS rate was 61% in the control arm and 77% in the bevacizumab arm. The 12-month OS rates were 30% and 43%, respectively.
The median PFS was 2.4 months in the control arm and 5.6 months in the bevacizumab arm (HR, 0.44; 95% CI, 0.36-0.54; P <.001). The 6-month PFS rate was 16% in the control arm and 43% in the bevacizumab arm. The 12-month PFS rates were 1% and 16%, respectively.
The disease control rate was 47.0% in the control arm and 76.6% in the bevacizumab arm (P <.001). Overall response rates were 0.9% and 6.3%, respectively (P =.004).
Adverse events (AEs) of grade 3 or higher were reported in 70% of patients in the control arm and 72% in the bevacizumab arm. AEs leading to study withdrawal were reported in 13% of patients in each arm. No treatment-related deaths were reported.
“The combination of trifluridine/tipiracil plus bevacizumab represents a new standard of care for the treatment of patients with refractory metastatic colorectal cancer who had previously progressed after 2 lines of therapy,” Dr Tabernero concluded.
Disclosures: This research was supported by Servier and Taiho Oncology, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Tabernero J, Prager GW, Fakih M, et al. Trifluridine/tipiracil plus bevacizumab for third-line treatment of refractory metastatic colorectal cancer: The phase 3 randomized SUNLIGHT study. ASCO GI 2023. January 19-21, 2023. Abstract 4.
