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Bending the Curve Trial by Trial
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REGARD

Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma

Phase 3N = 355NCT00917384

Population
Patients aged 24-87 years with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression after first-line platinum-containing or fluoropyrimidine-containing chemotherapy.
Design
International randomised double-blind placebo-controlled phase 3 trial at 119 centres in 29 countries, 2:1 to best supportive care plus ramucirumab 8 mg/kg or placebo intravenously every 2 weeks. Primary endpoint: overall survival, analysed by intention to treat.
Primary endpoint
OS
Arms
  • Placebo plus best supportive care (control, n = 117): Placebo intravenously every 2 weeks with best supportive care
  • Ramucirumab plus best supportive care (experimental, n = 238): Ramucirumab 8 mg/kg intravenously every 2 weeks with best supportive care
People
Fuchs CS, REGARD Trial Investigators
OSHR 0.776 (95% CI 0.603–0.998)Δ median OS+1.4 months
Show the numbers
Results reported for REGARD
EndpointAnalysisRamucirumab plus best supportive carePlacebo plus best supportive careEffect
OSprimaryFuchs 2014median 5.2 monthsmedian 3.8 monthsHR 0.776 (95% CI 0.603–0.998)P=0.047The abstract gives the interquartile ranges (2.3-9.9 and 1.7-7.1 months), not confidence intervals, for the medians. Hypertension 16% (38 patients) with ramucirumab versus 8% (9 patients) with placebo.
Results reported for REGARD
EndpointAnalysisRamucirumab plus best supportive carePlacebo plus best supportive careEffect
OSprimaryFuchs 2014median 5.2 monthsmedian 3.8 monthsHR 0.776 (95% CI 0.603–0.998)P=0.047The abstract gives the interquartile ranges (2.3-9.9 and 1.7-7.1 months), not confidence intervals, for the medians. Hypertension 16% (38 patients) with ramucirumab versus 8% (9 patients) with placebo.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.7760.603–0.998
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%024681012Months (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%
367.0%57.9%
739.3%27.9%
1026.4%16.1%
1317.7%9.3%
Primary publication: Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39. PubMedDOI

Appears in

Sources

  1. Fuchs CS, Tomasek J, Yong CJ, Dumitru F, Passalacqua R, Goswami C, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383(9911):31-39.

    PubMedDOI