Positive Results from Phase III TALENTACE Study of Tecentriq and Avastin for Unresectable Hepatocellular Carcinoma

• Announcing the results of the TALENTACE study for unresectable hepatocellular carcinoma eligible for transarterial chemoembolization (TACE) without prior systemic treatment
• The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS), and overall survival (OS) is immature at the prespecified first interim analysis.
• The safety profiles of Tecentriq and Avastin were consistent with their known safety profiles.

TOKYO, May 21, 2025 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that the Phase III TALENTACE study, evaluating the efficacy and safety of Tecentriq^® (atezolizumab), Avastin^® (bevacizumab), and on-demand transarterial chemoembolization (TACE) in people with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic treatment, met its primary endpoint with positive results.

The study demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of TACE-progression-free survival (TACE PFS*), and the other primary endpoint of overall survival (OS) is immature at the prespecified first interim analysis. Meanwhile, a clinically meaningful PFS by RECIST v1.1** was also observed. Detailed findings from this study will be presented at an upcoming academic congress.
*TACE PFS: Defined as the time from randomization to untreatable progression or TACE failure/refractoriness or death by any cause as determined by the investigator, and OS (overall survival), defined as time from randomization to death from any cause.
**RECIST v1.1: Response Evaluation Criteria in Solid Tumors guideline

Initiated in collaboration in China and Japan, the TALENTACE study aimed to assess whether combining Tecentriq and Avastin with TACE could improve outcomes for patients with unresectable HCC. This marks the Phase III study in Asia showing a TACE PFS benefit from cancer immunotherapy and target therapy in combination with TACE for unresectable HCC. The safety profiles of atezolizumab and bevacizumab were consistent with the well-established safety profile of each therapeutic agent and the underlying disease.

About the TALENTACE Study

TALENTACE study is a phase III, open-label, randomized study of on-demand transarterial chemoembolization (TACE) combined with Tecentriq + Avastin or on-demand transarterial chemoembolization (TACE) alone in patients with unresectable hepatocellular carcinoma who have not received prior systemic treatment. The TALENTACE study enrolled 342 patients in China and Japan who were randomized on a 1:1 ratio to receive TACE + Tecentriq/Avastin or TACE alone. TACE was performed on-demand. The co-primary endpoints are TACE PFS (TACE progression-free survival) and OS (overall survival). Secondary endpoints include PFS by RECIST v1.1 and others.

 About Liver cancer

Liver cancer is the third leading cause of cancer-related death globally and one of the few cancers with rising mortality rates.^1,2 More than 500,000 people are diagnosed with liver cancer every year, translating to one person being diagnosed every 50 seconds.¹ Despite advances in treatment, only one in five people with liver cancer are alive five years post-diagnosis, and survival rates for advanced disease are even lower.³

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Sources

1. IARC: Statistics at a glance. Fact-sheet, 2022: [Internet; cited May 2025] Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
2. Sung H, et al. CA Cancer J Clin 2021;71:209–249.
3. American Cancer Society. 5-year relative survival rates for liver cancer. [Internet; cited May 2025] Available at: https://www.cancer.org/cancer/types/liver-cancer/detection-diagnosis-staging/survival-rates.html