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FRESCO-2

A Global Multicenter Randomized Placebo-Controlled Phase 3 Trial To Compare The Efficacy And Safety Of Fruquintinib Plus Best Supportive Care To Placebo Plus Best Supportive Care In Patients With Refractory Metastatic Colorectal Cancer

Phase 3N = 691NCT04322539

Population
Metastatic colorectal adenocarcinoma in patients who had received all standard approved cytotoxic and targeted therapies and progressed on or were intolerant to trifluridine-tipiracil or regorafenib, or both
Design
International, randomised, double-blind, placebo-controlled phase 3 trial at 124 hospitals and cancer centres in 14 countries; 2:1 randomisation to fruquintinib 5 mg or matched placebo once daily on days 1 to 21 of 28-day cycles, plus best supportive care. Stratified by previous trifluridine-tipiracil or regorafenib or both, RAS mutation status and duration of metastatic disease. The primary endpoint was overall survival; the final analysis took place after 480 deaths.
Primary endpoint
OS
Arms
  • Placebo + best supportive care (control, n = 230): Matched placebo once daily on days 1 to 21 of 28-day cycles, plus best supportive care
  • Fruquintinib + best supportive care (experimental, n = 461): Fruquintinib 5 mg once daily on days 1 to 21 of 28-day cycles, plus best supportive care
People
Dasari A
OSHR 0.66 (95% CI 0.55–0.80)Δ median OS+2.6 months
Show the numbers
Results reported for FRESCO-2
EndpointAnalysisFruquintinib + best supportive carePlacebo + best supportive careEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryDasari 2023median 7.4 months (6.7–8.2)median 4.8 months (4.0–5.8)HR 0.66 (95% CI 0.55–0.80)P<0.0001Patients had received a median of 4 previous lines of systemic therapy for metastatic disease (IQR 3 to 6).
Results reported for FRESCO-2
EndpointAnalysisFruquintinib + best supportive carePlacebo + best supportive careEffect
OSAll randomised patients (analysis population not stated in the abstract)Overall survival (primary endpoint)primaryDasari 2023median 7.4 months (6.7–8.2)median 4.8 months (4.0–5.8)HR 0.66 (95% CI 0.55–0.80)P<0.0001Patients had received a median of 4 previous lines of systemic therapy for metastatic disease (IQR 3 to 6).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.660.55–0.8
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%051015Months (modelled)
  • Fruquintinib + best supportive care (experimental)
  • Placebo + best supportive care (control)

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

Data table (modelled values)
MonthsFruquintinib + best supportive carePlacebo + best supportive care
0100.0%100.0%
562.6%48.6%
943.0%27.3%
1426.9%13.2%
1916.9%6.4%
Primary publication: Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53. PubMedDOI

Appears in

Sources

  1. Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53.

    PubMedDOI