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IMmotion010

Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010)

Phase 3N = 778NCT03024996

Population
Adults with renal cell carcinoma with a clear cell or sarcomatoid component and increased risk of recurrence, after nephrectomy with or without metastasectomy.
Design
Multicentre, randomised (1:1), double-blind phase 3 trial in 215 centres in 28 countries, January 2017 to February 2019. Atezolizumab 1200 mg or placebo intravenously every 3 weeks for 16 cycles or 1 year. Primary endpoint investigator-assessed disease-free survival in the intention-to-treat population. The trial is closed to accrual; the ClinicalTrials.gov status is terminated with 778 enrolled.
Primary endpoint
DFS
Arms
  • Atezolizumab (experimental, n = 390): Atezolizumab 1200 mg intravenously every 3 weeks for 16 cycles or 1 year
  • Placebo (control, n = 388): Placebo intravenously every 3 weeks for 16 cycles or 1 year
People
Pal SK
DFSHR 0.93 (95% CI 0.75–1.15)Δ median DFS+7.7 months
Show the numbers
Results reported for IMmotion010
EndpointAnalysisAtezolizumabPlaceboEffect
DFSInvestigator-assessed disease-free survival.primarymedian follow-up 44.7 monthsPal 2022median 57.2 monthsmedian 49.5 monthsHR 0.93 (95% CI 0.75–1.15)P=0.50The 95% confidence intervals of the medians were 44.6 to not evaluable (atezolizumab) and 47.4 to not evaluable (placebo). Serious adverse events occurred in 69 (18%) patients on atezolizumab and 46 (12%) on placebo; there were no treatment-related deaths.
Results reported for IMmotion010
EndpointAnalysisAtezolizumabPlaceboEffect
DFSInvestigator-assessed disease-free survival.primarymedian follow-up 44.7 monthsPal 2022median 57.2 monthsmedian 49.5 monthsHR 0.93 (95% CI 0.75–1.15)P=0.50The 95% confidence intervals of the medians were 44.6 to not evaluable (atezolizumab) and 47.4 to not evaluable (placebo). Serious adverse events occurred in 69 (18%) patients on atezolizumab and 46 (12%) on placebo; there were no treatment-related deaths.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.930.75–1.15
Illustrative — modelled from reported values, not trial data. DFS, primary.
0%25%50%75%100%020406080100120140Months (modelled)
  • Atezolizumab (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsAtezolizumabPlacebo
0100.0%100.0%
3664.6%60.4%
7241.8%36.5%
10727.3%22.4%
14317.7%13.5%
Primary publication: Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, et al. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022;400(10358):1103-1116. PubMedDOI

Appears in

Sources

  1. Pal SK, Uzzo R, Karam JA, Master VA, Donskov F, Suarez C, et al. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial. Lancet. 2022;400(10358):1103-1116.

    PubMedDOI