IMvoke010
Trial question
What is the effect of atezolizumab in patients with locally advanced head and neck SCC?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
16.0% female
84.0% male
N = 406
406 patients (64 female, 342 male).
Inclusion criteria: patients with locally advanced head and neck SCC.
Key exclusion criteria: prior treatment with immune checkpoint inhibitors; metastatic disease; SCC of the nasopharynx or paranasal sinuses or non-squamous histology; uncontrolled or symptomatic hypercalcemia; autoimmune disease or immune deficiency; active tuberculosis; significant CVD; prior allogeneic stem cell or solid organ transplantation.
Interventions
N=203 atezolizumab (at a dose of 1,200 mg intravenous infusion every 3 weeks).
N=203 placebo (matching placebo intravenous infusion every 3 weeks).
Primary outcome
Median event-free survival
59.5 months
52.7 months
59.5 months
44.6 months
29.8 months
14.9 months
0.0 months
Atezolizumab
Placebo
No significant
difference ↔
No significant difference in median event-free survival (59.5 months vs. 52.7 months; HR 1.06, 95% CI 0.79 to 1.43).
Safety outcomes
No significant difference in ≥ 1 adverse event.
Conclusion
In patients with locally advanced head and neck SCC, atezolizumab was not superior to placebo with respect to median event-free survival.
Reference
Robert Haddad, Jérôme Fayette, Maria Teixeira et al. Atezolizumab in High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomized Clinical Trial. JAMA. 2025 Mar 13:e251483. Online ahead of print.
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