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IMpassion130

Needs review

Atezolizumab plus nab-paclitaxel versus placebo plus nab-paclitaxel in untreated metastatic triple-negative breast cancer

Phase 3N = 902NCT02425891

Population
Untreated unresectable locally advanced or metastatic triple-negative breast cancer; PD-L1-positive defined as PD-L1 on tumor-infiltrating immune cells in at least 1% of the tumor area
Design
Randomised 1:1, double-blind, placebo-controlled phase 3 trial; atezolizumab 840 mg (days 1 and 15) or placebo with nab-paclitaxel 100 mg per square metre (days 1, 8, 15) of 28-day cycles until progression or unacceptable toxicity. Stratified by prior taxane, liver metastases and PD-L1 status (SP142 assay). Co-primary endpoints PFS (ITT and PD-L1-positive) and OS (tested hierarchically).
Primary endpoint
PFS, OS
Arms
  • Atezolizumab plus nab-paclitaxel (experimental, n = 451): Atezolizumab 840 mg plus nab-paclitaxel 100 mg/m2
  • Placebo plus nab-paclitaxel (control, n = 451): Placebo plus nab-paclitaxel 100 mg/m2
People
Schmid P, IMpassion130 Trial Investigators
PFSHR 0.80 (95% CI 0.69–0.92)Δ median PFS+1.7 monthsPFSHR 0.62 (95% CI 0.49–0.78)Δ median PFS+2.5 monthsOSHR 0.84 (95% CI 0.69–1.02)Δ median OS+3.7 months
Show the numbers
Results reported for IMpassion130
EndpointAnalysisAtezolizumab plus nab-paclitaxelPlacebo plus nab-paclitaxelEffect
PFSprimarymedian follow-up 12.9 monthsSchmid 2018median 7.2 monthsmedian 5.5 monthsHR 0.80 (95% CI 0.69–0.92)P=0.002
PFSPD-L1-positive subgroupprimarymedian follow-up 12.9 monthsSchmid 2018median 7.5 monthsmedian 5 monthsHR 0.62 (95% CI 0.49–0.78)P<0.001
OSinterimmedian follow-up 12.9 monthsSchmid 2018median 21.3 monthsmedian 17.6 monthsHR 0.84 (95% CI 0.69–1.02)P=0.08Hierarchical testing: OS in the PD-L1-positive subgroup was to be tested only if the ITT result was significant.
OSPD-L1-positive subgroupinterimmedian follow-up 12.9 monthsSchmid 2018median 25 monthsmedian 15.5 monthsHR 0.62 (95% CI 0.45–0.86)No P value is given for this subgroup in the abstract.
OSfinalmedian follow-up 18.8 monthsEmens 2021median 21 months (19.0–23.4)median 18.7 months (16.9–20.8)HR 0.87 (95% CI 0.75–1.02)P=0.077Stratified hazard ratio. The abstract states the ITT OS difference was not statistically significant, precluding formal testing in the PD-L1-positive population.
OSPD-L1 IC-positive (n = 185 and 184), exploratoryexploratorymedian follow-up 18.8 monthsEmens 2021median 25.4 months (19.6–30.7)median 17.9 months (13.6–20.3)HR 0.67 (95% CI 0.53–0.86)Exploratory analysis; stratified hazard ratio.
Results reported for IMpassion130
EndpointAnalysisAtezolizumab plus nab-paclitaxelPlacebo plus nab-paclitaxelEffect
PFSprimarymedian follow-up 12.9 monthsSchmid 2018median 7.2 monthsmedian 5.5 monthsHR 0.80 (95% CI 0.69–0.92)P=0.002
PFSPD-L1-positive subgroupprimarymedian follow-up 12.9 monthsSchmid 2018median 7.5 monthsmedian 5 monthsHR 0.62 (95% CI 0.49–0.78)P<0.001
OSinterimmedian follow-up 12.9 monthsSchmid 2018median 21.3 monthsmedian 17.6 monthsHR 0.84 (95% CI 0.69–1.02)P=0.08Hierarchical testing: OS in the PD-L1-positive subgroup was to be tested only if the ITT result was significant.
OSPD-L1-positive subgroupinterimmedian follow-up 12.9 monthsSchmid 2018median 25 monthsmedian 15.5 monthsHR 0.62 (95% CI 0.45–0.86)No P value is given for this subgroup in the abstract.
OSfinalmedian follow-up 18.8 monthsEmens 2021median 21 months (19.0–23.4)median 18.7 months (16.9–20.8)HR 0.87 (95% CI 0.75–1.02)P=0.077Stratified hazard ratio. The abstract states the ITT OS difference was not statistically significant, precluding formal testing in the PD-L1-positive population.
OSPD-L1 IC-positive (n = 185 and 184), exploratoryexploratorymedian follow-up 18.8 monthsEmens 2021median 25.4 months (19.6–30.7)median 17.9 months (13.6–20.3)HR 0.67 (95% CI 0.53–0.86)Exploratory analysis; stratified hazard ratio.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSPFSOSOSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.80.69–0.92
PFS0.620.49–0.78
OS0.840.69–1.02
OS0.620.45–0.86
OS0.870.75–1.02
OS0.670.53–0.86
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Atezolizumab plus nab-paclitaxel (experimental)
  • Placebo plus nab-paclitaxel (control)

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

Data table (modelled values)
MonthsAtezolizumab plus nab-paclitaxelPlacebo plus nab-paclitaxel
0100.0%100.0%
561.8%53.3%
942.0%32.2%
1426.0%17.1%
1817.7%10.3%
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Atezolizumab plus nab-paclitaxel (experimental)
  • Placebo plus nab-paclitaxel (control)

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

Data table (modelled values)
MonthsAtezolizumab plus nab-paclitaxelPlacebo plus nab-paclitaxel
0100.0%100.0%
563.0%50.0%
943.5%28.7%
1427.4%14.4%
1917.3%7.2%
Primary publication: Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018;379(22):2108-2121. PubMedDOI

Appears in

Sources

  1. Schmid P, Adams S, Rugo HS, Schneeweiss A, Barrios CH, Iwata H, et al. Atezolizumab and Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2018;379(22):2108-2121.

    PubMedDOI

  2. Emens LA, Adams S, Barrios CH, Diéras V, Iwata H, Loi S, et al. First-line atezolizumab plus nab-paclitaxel for unresectable, locally advanced, or metastatic triple-negative breast cancer: IMpassion130 final overall survival analysis. Ann Oncol. 2021;32(8):983-993.

    PubMedDOI