Roche Announces Phase III TALENTACE Study Met Primary Endpoint in Unresectable Hepatocellular Carcinoma

Roche today announced that the Phase III TALENTACE study met its primary endpoint. The study evaluated the efficacy and safety of atezolizumab, bevacizumab, and on-demand transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic treatment. The study showed,The primary endpoint, TACE progression-free survival (TACE-PFS, the time from randomization to investigator-assessed TACE untreatable progression or TACE failure/resistance or death from any cause), was achieved.StatisticsSignificant improvement in both academic and clinical terms, the overall survival (OS) was not yet mature at the interim analysis. Meanwhile, a clinically meaningful improvement was observed in the PFS assessed by RECIST v1.1.

The Annual New Cases of Liver Cancer Exceed 800,000 with Mortality Rates Continuously Rising^[1,2]More than 60% of new liver cancer cases in the Asian region occur in China.^[3,4]Clinical studies have confirmed that 90% of HCC cases are associated with the progression of chronic liver disease, mainly including viral hepatitis (HBV/Hepatitis C), MetabolismDysfunctionRelated fatty liver disease and alcoholic liver disease, etc., caused byLiver Cirrhosis^[5]. Despite continuous advancements in diagnostic and treatment technologies in recent years, the five-year survival rate for patients with advanced liver cancer remains below 10%.^[6]。

TACE, as a common local treatment method for unresectable liver cancer, exerts its anti-tumor effect by blocking the tumor blood supply and releasing local chemotherapy drugs. In recent years, withImmunityCombined targeted therapy establishes standard treatment地位 in advanced liver cancer, and the "local + systemic" combination strategy becomes a research hotspot.

TALENTACE Study Initiated and Participated by Leading Medical Centers in China and JapanThe principal investigator is Professor Dong Jiahong from the Liver, Gallbladder, and Pancreas Center (Liver and Gallbladder Hospital) of Beijing Tsinghua Changgung Hospital.TALENTACE Study Pioneeringly Explores the Combination of Immune Checkpoint Inhibitor Atezolizumab with Anti-Blood VesselGenerateTargeted TherapyThe Synergistic Effect of Bevacizumab Combined with On-Demand TACE in Concurrent Treatment; Meanwhile,TALENTACE Study InnovativelyTACE-PFS as the primary endpoint, demonstrating treatment benefit in untreated intermediate- to high-tumor-burden HCC patients.，It is expected to provide high-level evidence for the combined treatment model of local tumor control and systemic molecular intervention in liver cancer.

Analysis of the study data shows that the safety profiles of atezolizumab and bevacizumab are consistent with previous data and underlying conditions. Detailed results of the study will be presented at upcoming international academic conferences.

"We are very pleased to see the interim results achieved in the TALENTACE study and look forward to the release of the full data in the future. Roche has always been committed to addressing local clinical needs in China, striving to improve the landscape of liver cancer diagnosis and treatment through breakthrough therapies, and upholding its long-term commitment in the field of gastrointestinal tumors. Moving forward, Roche will continue to strengthen global research collaborations, working with all parties to accelerate access to innovative therapies, contributing to the 'Healthy China 2030' goals for cancer prevention and treatment."

TALENTACE (NCT04712643) is a Phase III open-label randomized controlled trial, with participants being patients with hepatocellular carcinoma who have not received systemic therapy. The study regimen consists of on-demand transarterial chemoembolization (TACE) combined with atezolizumab and bevacizumab, or on-demand TACE alone.

TALENTACE Study Enrolls 342 Patients with HCC in China and Japan; Meets TACE Treatment Criteria, No Prior Systemic Therapy, and Maximum Tumor Diameter + Number of Lesions ≥6. Patients were randomized 1:1 to receive either TACE + Atezolizumab + Bevacizumab or TACE alone. TACE was performed at the investigator's discretion as needed. Atezolizumab and Bevacizumab were administered between 14 days and 8 weeks post-TACE (Atezolizumab 1200mg IV; Bevacizumab 15mg/kg IV; both given every 3 weeks until loss of clinical benefit).

The co-primary endpoints are TACE-PFS (TACE progression-free survival), defined as the time from randomization to investigator-assessed TACE-untreatable [unTACEable] progression or TACE failure/resistance or death from any cause; and OS (overall survival), defined as the time from randomization to death from any cause. Secondary endpoints include PFS assessed by RECIST v1.1, time to TACE-untreatable progression (TTUP), time to progression (TTP), time to EHS, ORR, DOR, and time to deterioration (TTD).