Chugai files Tecentriq for maintenance therapy after definitive chemoradiotherapy in locally advanced esophageal cancer

Regulatory filing

Chugai Pharmaceutical has submitted a regulatory application to Japan’s Ministry of Health, Labour and Welfare for Tecentriq (atezolizumab) 1200 mg intravenous infusion as maintenance therapy following definitive chemoradiotherapy in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed.

Trial evidence

The filing is supported by data from the global Phase III SKYSCRAPER‑07 (YO42137) randomized, double‑blind, multicenter study. Based on the first and second interim analyses, the Tecentriq monotherapy arm continued to show clinical benefit for the primary endpoint of overall survival and the secondary endpoint of investigator‑assessed progression‑free survival. The second interim analysis results are planned for presentation at an upcoming medical congress.

Study design and development decisions

SKYSCRAPER‑07 compared Tecentriq plus tiragolumab, Tecentriq monotherapy, and placebo in patients whose cancers had not progressed after definitive concurrent chemoradiotherapy. Development of the Tecentriq plus tiragolumab combination was discontinued after the primary PFS analysis and the first interim OS analysis (data cutoff 18 February 2025) showed no clinical benefit.

Clinical context and safety

The safety profile observed in SKYSCRAPER‑07 was consistent with Tecentriq’s known safety profile with no new safety signals reported. The submission targets a setting where no established standard exists for maintenance therapy after definitive chemoradiotherapy in unresectable, locally advanced esophageal squamous cell carcinoma.