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Bending the Curve Trial by Trial
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IMpower010

Needs review

Adjuvant atezolizumab versus best supportive care after adjuvant platinum-based chemotherapy in resected stage IB-IIIA non-small-cell lung cancer

Phase 3N = 1,005NCT02486718

Population
Completely resected stage IB (tumours 4 cm or larger) to IIIA NSCLC (UICC/AJCC 7th edition) after adjuvant platinum-based chemotherapy
Design
Randomised (1:1), multicentre, open-label phase 3 study at 227 sites in 22 countries and regions. After complete resection and 1 to 4 cycles of adjuvant platinum-based chemotherapy, atezolizumab 1200 mg every 21 days (16 cycles or 1 year) or best supportive care (observation and regular scans). 1280 patients were enrolled after resection; 1269 received adjuvant chemotherapy and 1005 were eligible for randomisation.
Primary endpoint
DFS
Arms
  • Atezolizumab (experimental, n = 507): Atezolizumab 1200 mg every 21 days for 16 cycles or 1 year
  • Best supportive care (control, n = 498): Observation and regular scans for disease recurrence
People
Felip E, IMpower010 Investigators
DFSHR 0.66 (95% CI 0.50–0.88)DFSHR 0.79 (95% CI 0.64–0.96)DFSHR 0.81 (95% CI 0.67–0.99)
Show the numbers
Results reported for IMpower010
EndpointAnalysisAtezolizumabBest supportive careEffect
DFSStage II-IIIA with PD-L1 on at least 1% of tumour cells (SP263)Investigator-assessed disease-free survivalprimarymedian follow-up 32.2 monthsFelip 2021——HR 0.66 (95% CI 0.50–0.88)P=0.0039First step of the hierarchical test of the primary endpoint. Median follow-up 32.2 months (IQR 27.4 to 38.3) in the stage II-IIIA population.
DFSAll patients in the stage II-IIIA populationInvestigator-assessed disease-free survivalprimarymedian follow-up 32.2 monthsFelip 2021——HR 0.79 (95% CI 0.64–0.96)P=0.020Second step of the hierarchical test.
DFSITT (stage IB-IIIA)Investigator-assessed disease-free survivalprimaryFelip 2021——HR 0.81 (95% CI 0.67–0.99)P=0.040Final step of the hierarchical test of the primary endpoint. Atezolizumab-related grade 3 or 4 adverse events: 11% (53 of 495).
Results reported for IMpower010
EndpointAnalysisAtezolizumabBest supportive careEffect
DFSStage II-IIIA with PD-L1 on at least 1% of tumour cells (SP263)Investigator-assessed disease-free survivalprimarymedian follow-up 32.2 monthsFelip 2021——HR 0.66 (95% CI 0.50–0.88)P=0.0039First step of the hierarchical test of the primary endpoint. Median follow-up 32.2 months (IQR 27.4 to 38.3) in the stage II-IIIA population.
DFSAll patients in the stage II-IIIA populationInvestigator-assessed disease-free survivalprimarymedian follow-up 32.2 monthsFelip 2021——HR 0.79 (95% CI 0.64–0.96)P=0.020Second step of the hierarchical test.
DFSITT (stage IB-IIIA)Investigator-assessed disease-free survivalprimaryFelip 2021——HR 0.81 (95% CI 0.67–0.99)P=0.040Final step of the hierarchical test of the primary endpoint. Atezolizumab-related grade 3 or 4 adverse events: 11% (53 of 495).
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFSDFSDFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.660.5–0.88
DFS0.790.64–0.96
DFS0.810.67–0.99
Primary publication: Felip E, Altorki N, Zhou C, Csőszi T, Vynnychenko I, Goloborodko O, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398(10308):1344-1357. PubMedDOI

Appears in

Sources

  1. Felip E, Altorki N, Zhou C, Csőszi T, Vynnychenko I, Goloborodko O, et al. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021;398(10308):1344-1357.

    PubMedDOI