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EMILIA

A Randomized, Multicenter, Phase III Open-label Study of the Efficacy and Safety of Trastuzumab MCC-DM1 vs. Capecitabine + Lapatinib in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

Phase 3N = 991NCT00829166

Population
HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane
Design
Randomised phase 3 trial of trastuzumab emtansine versus lapatinib plus capecitabine; two interim analyses of overall survival were conducted.
Primary endpoint
PFS, OS
Arms
  • Lapatinib plus capecitabine (control): Lapatinib plus capecitabine
  • Trastuzumab emtansine (T-DM1) (experimental): Trastuzumab emtansine
People
Verma S
PFSHR 0.65 (95% CI 0.55–0.77)Δ median PFS+3.2 monthsOSHR 0.68 (95% CI 0.55–0.85)Δ median OS+5.8 monthsΔ ORR+12.8 points
Show the numbers
Results reported for EMILIA
EndpointAnalysisTrastuzumab emtansine (T-DM1)Lapatinib plus capecitabineEffect
PFSAll randomised patients (991)PFS assessed by independent reviewprimaryVerma 2012median 9.6 monthsmedian 6.4 monthsHR 0.65 (95% CI 0.55–0.77)P<0.001
OSAll randomised patients (991)interimVerma 2012median 30.9 monthsmedian 25.1 monthsHR 0.68 (95% CI 0.55–0.85)P<0.001Second interim analysis; crossed the stopping boundary for efficacy.
ORRAll randomised patients (991)primaryVerma 201243.6%30.8%P<0.001Secondary endpoint.
Results reported for EMILIA
EndpointAnalysisTrastuzumab emtansine (T-DM1)Lapatinib plus capecitabineEffect
PFSAll randomised patients (991)PFS assessed by independent reviewprimaryVerma 2012median 9.6 monthsmedian 6.4 monthsHR 0.65 (95% CI 0.55–0.77)P<0.001
OSAll randomised patients (991)interimVerma 2012median 30.9 monthsmedian 25.1 monthsHR 0.68 (95% CI 0.55–0.85)P<0.001Second interim analysis; crossed the stopping boundary for efficacy.
ORRAll randomised patients (991)primaryVerma 201243.6%30.8%P<0.001Secondary endpoint.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.650.55–0.77
OS0.680.55–0.85
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Lapatinib plus capecitabine (control)
  • Trastuzumab emtansine (T-DM1) (experimental)

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

Data table (modelled values)
MonthsLapatinib plus capecitabineTrastuzumab emtansine (T-DM1)
0100.0%100.0%
652.2%64.8%
1227.3%42.0%
1814.2%27.3%
247.4%17.7%
Illustrative — modelled from reported values, not trial data. OS, interim.
0%25%50%75%100%0204060Months (modelled)
  • Lapatinib plus capecitabine (control)
  • Trastuzumab emtansine (T-DM1) (experimental)

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

Data table (modelled values)
MonthsLapatinib plus capecitabineTrastuzumab emtansine (T-DM1)
0100.0%100.0%
1959.2%65.3%
3934.1%41.7%
5820.2%27.2%
7711.9%17.8%
Primary publication: Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-91. PubMedDOI

Appears in

Sources

  1. Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-91.

    PubMedDOI