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Bending the Curve Trial by Trial
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REACH

Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial

Phase 3N = 565NCT01140347

Population
Patients with advanced hepatocellular carcinoma who had previously received sorafenib; no alpha-fetoprotein threshold
Design
Randomised (1:1), placebo-controlled, double-blind, multicentre phase 3 trial at 154 centres in 27 countries; ramucirumab 8 mg/kg or placebo every 2 weeks plus best supportive care. Eligible patients had BCLC stage C, or stage B refractory or not amenable to locoregional therapy, Child-Pugh A, ECOG performance status 0 or 1, and previous sorafenib (stopped for progression or intolerance). Primary endpoint overall survival in the intention-to-treat population.
Primary endpoint
OS
Arms
  • Ramucirumab plus best supportive care (experimental, n = 283): Ramucirumab 8 mg/kg intravenously every 2 weeks
  • Placebo plus best supportive care (control, n = 282): Placebo every 2 weeks
People
Zhu AX, REACH Trial Investigators
OSHR 0.87 (95% CI 0.72–1.05)Δ median OS+1.6 months
Show the numbers
Results reported for REACH
EndpointAnalysisRamucirumab plus best supportive carePlacebo plus best supportive careEffect
OSprimaryZhu 2015median 9.2 months (8.0–10.6)median 7.6 months (6.0–9.3)HR 0.87 (95% CI 0.72–1.05)P=0.14
Results reported for REACH
EndpointAnalysisRamucirumab plus best supportive carePlacebo plus best supportive careEffect
OSprimaryZhu 2015median 9.2 months (8.0–10.6)median 7.6 months (6.0–9.3)HR 0.87 (95% CI 0.72–1.05)P=0.14
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.870.72–1.05
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Ramucirumab plus best supportive care (experimental)
  • Placebo plus 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)
MonthsRamucirumab plus best supportive carePlacebo plus best supportive care
0100.0%100.0%
663.6%57.9%
1240.5%33.5%
1727.8%21.2%
2317.7%12.3%
Primary publication: Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015;16(7):859-70. PubMedDOI

Appears in

Sources

  1. Zhu AX, Park JO, Ryoo BY, Yen CJ, Poon R, Pastorelli D, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015;16(7):859-70.

    PubMedDOI