Tecentriq Filed for Additional Indication as Maintenance Therapy Following Definitive Chemoradiotherapy in Locally Advanced Esophageal Cancer

• If approved, Tecentriq is expected to become the first immune checkpoint inhibitor for maintenance therapy in patients with locally advanced esophageal cancer whose disease has not progressed following definitive chemoradiotherapy
• Filing based on results from the global Phase III clinical trial (SKYSCRAPER-07)

TOKYO, June 12, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) today announced that it has filed a regulatory application with the Ministry of Health, Labour and Welfare for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq^® Intravenous Infusion 1200 mg [generic name: atezolizumab (genetical recombination)] for an additional indication as maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer.

“There is no established standard treatment for maintenance therapy following definitive chemoradiotherapy for locally advanced esophageal cancer. In the SKYSCRAPER-07 study, Tecentriq monotherapy indicated a trend toward improvement in overall survival and progression-free survival compared with placebo. We will continue our efforts toward obtaining approval so that Tecentriq can be delivered to patients as a new therapeutic option as soon as possible,” said Chugai’s President and CEO, Dr. Osamu Okuda.

This filing is based on the results from the global Phase III clinical study (SKYSCRAPER-07/ YO42137)¹ in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study is a randomized, double-blind, multicenter trial comparing the efficacy and safety of maintenance therapy with Tecentriq in combination with tiragolumab (development discontinued) or Tecentriq monotherapy versus placebo. Based on the results from the first ² and second interim analyses, it was confirmed that the Tecentriq monotherapy arm continued to show clinical benefit in the primary endpoint of overall survival (OS) and the secondary endpoint of investigator-assessed progression-free survival (PFS). The results of the second interim analysis are planned to be presented at an upcoming medical congress. The safety profile was consistent with the known safety profile of Tecentriq, and no new safety signals were identified.

Chugai Pharmaceutical, a leading company in the oncology field, remains committed to addressing unmet medical needs in cancer treatment with innovative medicines, supporting patients and healthcare professionals.

About the SKYSCRAPER-07 (YO42137) study¹
SKYSCRAPER-07 is a global Phase III randomized, double-blind, multicenter study in patients with unresectable, locally advanced esophageal squamous cell carcinoma whose disease has not progressed following definitive chemoradiotherapy. The study evaluated the efficacy and safety of Tecentriq plus tiragolumab or Tecentriq monotherapy compared with placebo. Development of the Tecentriq plus tiragolumab combination was discontinued as no clinical benefit was observed in the primary PFS analysis and the first interim OS analysis (cutoff: February 18, 2025)².

About maintenance therapy following definitive chemoradiotherapy in locally advanced esophageal cancer³
Esophageal cancer has an incidence rate in Japan (2021) of 34.7 per 100,000 population for men and 7.7 per 100,000 population for women. The number of deaths from esophageal cancer in 2024 was 10,638, and the 5-year relative survival rate (2009–2011) was 41.5%.
In Japan, squamous cell carcinoma is the most common histologic type. In unresectable, locally advanced esophageal squamous cell carcinoma, there is no clearly established standard treatment for patients without disease progression after definitive chemoradiotherapy, and new treatment options are needed.

About Tecentriq⁴
Tecentriq is an immune checkpoint inhibitor designed to target PD-L1 (programmed death-ligand 1) expressed on tumor cells or tumor-infiltrating immune cells. PD-L1 binds to PD-1 and B7.1 receptors on T cells and suppresses T-cell function. By inhibiting this interaction, Tecentriq is considered to restore T-cell activity and promote immune response against tumor cells. In Japan, Tecentriq was launched in April 2018 and has obtained approval for 7 tumor types (extensive-stage small cell lung cancer, non-small cell lung cancer, breast cancer, hepatocellular carcinoma, alveolar soft part sarcoma, extranodal natural killer/T-cell lymphoma nasal type, and thymic carcinoma).

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Sources:

1. ClinicalTrials.gov. A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy (SKYSCRAPER-07) [Internet; cited June 2026] Available from:
   https://clinicaltrials.gov/study/NCT04543617
2. I. Chau, et al. SKYSCRAPER-07: A phase III, randomised study of atezolizumab (atezo) with or without tiragolumab (tira) in patients (pts) with unresectable esophageal squamous cell carcinoma (ESCC) that has not progressed following definitive concurrent chemoradiotherapy (dCRT) Presented at: ESMO Congress; 2025 October 17-21; Berlin, Germany. Abstract #2094O [Internet; cited June 2026] Available from:
   https://www.annalsofoncology.org/action/showPdf?pii=S0923-7534%2825%2903636-1
3. Cancer Information Service, National Cancer Center, Japan. [Internet; cited June 2026] Available from:
   https://ganjoho.jp/reg_stat/statistics/stat/cancer/4_esophagus.html (Japanese only)
4. Tecentriq Intravenous Infusion 840 mg / 1200 mg. Electronic Package Insert Information (Revised December 2025, 12th Edition)