Atezolizumab with or without tiragolumab in unresectable esophageal squamous-cell carcinoma following definitive concurrent chemoradiotherapy (SKYSCRAPER-07): a randomised, phase III study.
R H Xu, B C Cho, M Chen et al.
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In 30 seconds
SKYSCRAPER-07 was a global, randomised, placebo-controlled phase III trial of 760 adults with unresectable esophageal squamous-cell carcinoma after definitive concurrent chemoradiotherapy. It compared atezolizumab plus tiragolumab, atezolizumab alone (with placebo), and placebo. At a median survival follow-up of 25.0 months, the combination with tiragolumab did not significantly improve progression-free or overall survival versus placebo. Atezolizumab alone was associated with improved overall survival versus placebo (HR 0.69, 95% CI 0.52-0.91; descriptive P = 0.0085) and improved investigator-assessed progression-free survival (HR 0.74, 95% CI 0.58-0.93).
Key findings
- Atezolizumab plus tiragolumab did not significantly improve investigator-assessed progression-free survival versus placebo (HR 0.82, 95% CI 0.65-1.03, P = 0.0947).
- Overall survival with atezolizumab plus tiragolumab versus placebo was not significantly improved (HR 0.91, 95% CI 0.70-1.18, descriptive P = 0.4772).
- Atezolizumab plus placebo improved overall survival versus placebo (HR 0.69, 95% CI 0.52-0.91, descriptive P = 0.0085) and investigator-assessed progression-free survival (HR 0.74, 95% CI 0.58-0.93).
- Treatment-related adverse events occurred in 74.8%, 65.2%, and 55.4% of patients in the tiragolumab combination, atezolizumab, and placebo groups, respectively.
Why it matters
The trial distinguishes the outcomes of adding tiragolumab from those of atezolizumab alone after definitive chemoradiotherapy. The lack of significant benefit for the combination contrasts with improved survival outcomes in the atezolizumab group, while treatment-related adverse events were more frequent with active treatment than placebo. These results inform interpretation of post-chemoradiotherapy immunotherapy evidence in unresectable ESCC.
What to keep in mind
The primary endpoint was not met for atezolizumab plus tiragolumab versus placebo. The reported follow-up was a median of 25.0 months.