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Bending the Curve Trial by Trial
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SUNLIGHT

An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

Phase 3N = 492NCT04737187

Population
Adults with refractory metastatic colorectal cancer who had received no more than two previous chemotherapy regimens for advanced disease
Design
Open-label, randomised phase 3 trial; 1:1 randomisation to trifluridine-tipiracil plus bevacizumab or trifluridine-tipiracil alone. The primary endpoint was overall survival; secondary endpoints included progression-free survival and safety.
Primary endpoint
OS
Arms
  • Trifluridine-tipiracil (control, n = 246): Trifluridine-tipiracil alone
  • Trifluridine-tipiracil + bevacizumab (experimental, n = 246): Trifluridine-tipiracil plus bevacizumab
People
Prager GW
OSHR 0.61 (95% CI 0.49–0.77)Δ median OS+3.3 monthsPFSHR 0.44 (95% CI 0.36–0.54)Δ median PFS+3.2 months
Show the numbers
Results reported for SUNLIGHT
EndpointAnalysisTrifluridine-tipiracil + bevacizumabTrifluridine-tipiracilEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryPrager 2023median 10.8 monthsmedian 7.5 monthsHR 0.61 (95% CI 0.49–0.77)P<0.001
PFSAll randomised patients (analysis population not stated in the abstract)Progression-free survival (secondary endpoint)primaryPrager 2023median 5.6 monthsmedian 2.4 monthsHR 0.44 (95% CI 0.36–0.54)P<0.001
Results reported for SUNLIGHT
EndpointAnalysisTrifluridine-tipiracil + bevacizumabTrifluridine-tipiracilEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryPrager 2023median 10.8 monthsmedian 7.5 monthsHR 0.61 (95% CI 0.49–0.77)P<0.001
PFSAll randomised patients (analysis population not stated in the abstract)Progression-free survival (secondary endpoint)primaryPrager 2023median 5.6 monthsmedian 2.4 monthsHR 0.44 (95% CI 0.36–0.54)P<0.001
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSPFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.610.49–0.77
PFS0.440.36–0.54
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%0510152025Months (modelled)
  • Trifluridine-tipiracil + bevacizumab (experimental)
  • Trifluridine-tipiracil (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTrifluridine-tipiracil + bevacizumabTrifluridine-tipiracil
0100.0%100.0%
763.8%52.4%
1440.7%27.4%
2027.7%15.7%
2717.7%8.2%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%02468101214Months (modelled)
  • Trifluridine-tipiracil + bevacizumab (experimental)
  • Trifluridine-tipiracil (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsTrifluridine-tipiracil + bevacizumabTrifluridine-tipiracil
0100.0%100.0%
461.0%31.5%
742.0%13.2%
1125.6%4.2%
1417.7%1.8%
Primary publication: Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, et al. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023;388(18):1657-1667. PubMedDOI

Appears in

Sources

  1. Prager GW, Taieb J, Fakih M, Ciardiello F, Van Cutsem E, Elez E, et al. Trifluridine-Tipiracil and Bevacizumab in Refractory Metastatic Colorectal Cancer. N Engl J Med. 2023;388(18):1657-1667.

    PubMedDOI