Chugai Pharmaceutical Co., Ltd. announced today that its Phase III TALENTACE study has met its primary endpoint, showing significant clinical benefit when combining Tecentriq (atezolizumab) and Avastin (bevacizumab) with on-demand transarterial chemoembolization (TACE) in previously untreated patients with unresectable hepatocellular carcinoma (HCC).
The trial demonstrated a statistically significant and clinically meaningful improvement in TACE-progression-free survival (TACE PFS), defined as the time from randomization to untreatable progression, TACE failure/refractoriness, or death from any cause. While the overall survival (OS) data remains immature at the prespecified first interim analysis, researchers also observed a clinically meaningful progression-free survival according to RECIST v1.1 criteria.
Groundbreaking Results for Liver Cancer Treatment
The TALENTACE study represents a significant advancement in the treatment landscape for unresectable HCC, particularly in Asian populations where liver cancer incidence is notably high. This marks the first Phase III study in Asia demonstrating a TACE PFS benefit from combining cancer immunotherapy and targeted therapy with TACE for unresectable HCC.
"These results are particularly encouraging given the limited treatment options and poor prognosis for patients with unresectable HCC," said a spokesperson from Chugai Pharmaceutical. "The combination of Tecentriq and Avastin with TACE could potentially offer a new standard of care for these patients."
The safety profiles of atezolizumab and bevacizumab observed in the study were consistent with the well-established safety profiles of each therapeutic agent and the underlying disease, with no new safety signals identified.
Study Design and Patient Population
The TALENTACE study was an open-label, randomized Phase III trial conducted in collaboration between China and Japan. The study enrolled 342 patients with unresectable HCC who had not received prior systemic treatment. Participants were randomized in a 1:1 ratio to receive either TACE plus Tecentriq and Avastin or TACE alone, with TACE performed on an on-demand basis.
The co-primary endpoints of the study were TACE PFS and overall survival. Secondary endpoints included progression-free survival according to RECIST v1.1 criteria and other measures. Detailed findings from the study will be presented at an upcoming academic congress.
Addressing a Significant Unmet Need
Liver cancer represents a substantial global health burden as the third leading cause of cancer-related death worldwide and one of the few cancers with rising mortality rates. More than 500,000 people are diagnosed with liver cancer annually—equivalent to one person being diagnosed every 50 seconds.
Despite advances in treatment approaches, the prognosis for liver cancer remains poor, with only one in five patients surviving five years after diagnosis. Survival rates for advanced disease are even lower, highlighting the urgent need for more effective treatment strategies.
Mechanism of Action
The combination therapy leverages complementary mechanisms of action. Tecentriq is an immune checkpoint inhibitor that binds to PD-L1, blocking its interactions with PD-1 and B7.1 receptors and enabling T-cell activation. Avastin is an anti-VEGF therapy that inhibits angiogenesis, reducing tumor blood supply and potentially enhancing immune cell infiltration. TACE is a localized treatment that delivers chemotherapy directly to the tumor while blocking its blood supply.
This triple approach—combining systemic immunotherapy, anti-angiogenic therapy, and localized treatment—appears to provide enhanced efficacy compared to TACE alone, which has been a standard treatment for intermediate-stage HCC.
Future Implications
The positive results from the TALENTACE study could potentially change treatment paradigms for unresectable HCC, particularly in Asian populations where the disease burden is highest. If longer-term data continues to show benefit, this combination approach could be incorporated into clinical guidelines for the management of unresectable HCC.
Chugai Pharmaceutical, in collaboration with healthcare providers across Asia, will continue to monitor patients enrolled in the study to gather mature overall survival data and additional safety information. The company plans to engage with regulatory authorities to discuss the potential pathway for approval based on these positive findings.
