TALENTACE: A phase III, open-label, randomized study of on-demand transarterial chemoembolization combined with atezolizumab + bevacizumab or on-demand transarterial chemoembolization alone in patients with untreated hepatocellular carcinoma.

TPS487 Background: In 2020, there were ̃905, 000 new cases and ̃830, 000 deaths from liver cancer globally, and a respective 410, 038 and 391, 152 in China (5-year overall survival OS: 14. 1%). 1, 2, 3 Hepatocellular carcinoma (HCC) accounts for 75%–85% of liver cancers. 1 Transarterial chemoembolization (TACE) is the preferred treatment for patients with intermediate-stage unresectable HCC (uHCC) ; however, there are issues with the need for repeated dosing and the heterogenous target population (median OS: 13–43 mo). Treatment with TACE + systemic therapy may improve this. Although several trials reported negative results for TACE + sorafenib (sor) vs TACE alone in patients with uHCC, the TACTICS trial showed improved untreatable (unTACEable) progression-free survival (PFS) (25. 2 vs 13. 5 mo; P= 0. 006). 4 While promising, the unmet need for combination therapies remains. The recent IMbrave150 trial showed significantly improved OS with atezolizumab (atezo) + bevacizumab (bev) vs sor (19. 2 vs 13. 4 mo; P= 0. 0009) in patients with uHCC 5, making it an attractive option for combination with TACE. Methods: TALENTACE (NCT047126430) is a phase III, open-label, randomized study to evaluate the efficacy and safety of TACE + atezo + bev or TACE alone in patients with uHCC. Key inclusion criteria are ≥18 years old, HCC diagnosis, no prior systemic treatment, no prior locoregional treatment of target lesions, eligible for TACE treatment, tumor max diameter + tumor number ≥6, and not a candidate for curative therapy. Patients with tumors that have macrovascular invasion (MVI) or extrahepatic spread (EHS) are excluded. Patients will be randomized (1: 1) to receive TACE + atezo + bev or TACE alone. TACE will be performed by clinical demand; atezo (1200 mg) and bev (15 mg/kg) will be administered by intravenous infusion on Day 1 of each 21-day cycle. Co-primary endpoints are independent review committee-determined TACE-PFS (randomization to unTACEable progression, TACE failure/refractoriness, or death) and OS. Secondary endpoints include investigator-determined TACE-PFS; time to unTACEable progression, progression, MVI, EHS, and MVI/EHS; objective response rate, duration of response, patient reported outcomes, and incidence of adverse events. References: Sung, H. , et al. CA Cancer J Clin. 2021;71 (3): 209–249. World Health Organisation: Globocan 2020 – China Factsheet. Available at: https: //gco. iarc. fr/today/data/factsheets/populations/160-china-fact-sheets. pdf accessed 1 June 2021 Allemani, C. , et al. Lancet. 2018, 391 (10125): 1023–1075. Kudo, M. , et al. Gut. 2020;69 (8): 1492–1501. Finn, RS. , et al. J Clin Oncol. 2021;39 (no. 3ₛuppl): 267–267. Clinical trial information: NCT04712643.