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IMvoke010

Atezolizumab versus placebo after multimodal definitive treatment in high-risk locally advanced squamous cell carcinoma of the head and neck

Phase 3N = 406NCT03452137

Population
High-risk locally advanced squamous cell carcinoma of the head and neck without progression after multimodal definitive treatment
Design
Global, double-blind, randomised phase 3 trial at 128 sites in 23 countries. 406 patients with locally advanced SCCHN (stage IVa or IVb of the oral cavity, larynx, hypopharynx or HPV-negative oropharynx, or stage III HPV-positive oropharynx; AJCC eighth edition) without progression after multimodal definitive treatment were randomised 1:1 to atezolizumab 1200 mg or placebo every 3 weeks for 1 year or until recurrence, progression, unacceptable toxicity or withdrawal of consent. The primary end point was investigator-assessed event-free survival.
Primary endpoint
EFS
Arms
  • Atezolizumab (experimental, n = 203): Atezolizumab 1200 mg every 3 weeks for up to 1 year
  • Placebo (control, n = 203): Placebo every 3 weeks for up to 1 year
People
Haddad R, senior author Wong DJ
EFSHR 0.94 (95% CI 0.70–1.26)Δ median EFS+6.8 monthsΔ 24-month OS+2.8 points
Show the numbers
Results reported for IMvoke010
EndpointAnalysisAtezolizumabPlaceboEffect
EFSRandomised patients (N = 406)primarymedian follow-up 46.5 monthsHaddad 2025median 59.5 monthsmedian 52.7 monthsHR 0.94 (95% CI 0.70–1.26)P=0.68The 95% CIs for the medians (46.8 to not estimable; 41.4 to not estimable) have an upper bound that cannot be entered as a number.
OSRandomised patients (N = 406)primaryHaddad 202582% at 2 y79.2% at 2 yOverall survival was an additional end point; the abstract states there was no difference.
Results reported for IMvoke010
EndpointAnalysisAtezolizumabPlaceboEffect
EFSRandomised patients (N = 406)primarymedian follow-up 46.5 monthsHaddad 2025median 59.5 monthsmedian 52.7 monthsHR 0.94 (95% CI 0.70–1.26)P=0.68The 95% CIs for the medians (46.8 to not estimable; 41.4 to not estimable) have an upper bound that cannot be entered as a number.
OSRandomised patients (N = 406)primaryHaddad 202582% at 2 y79.2% at 2 yOverall survival was an additional end point; the abstract states there was no difference.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
EFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
EFS0.940.7–1.26
Illustrative — modelled from reported values, not trial data. EFS, 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%
3765.0%61.5%
7442.2%37.8%
11227.1%22.9%
14917.6%14.1%
Primary publication: Haddad R, Fayette J, Teixeira M, Prabhash K, Mesia R, Kawecki A, et al. Atezolizumab in High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA. 2025;333(18):1599-1607. PubMedDOI

Appears in

Sources

  1. Haddad R, Fayette J, Teixeira M, Prabhash K, Mesia R, Kawecki A, et al. Atezolizumab in High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA. 2025;333(18):1599-1607.

    PubMedDOI