92P - Safety of liver resection following atezolizumab plus bevacizumab treatment in hepatocellular carcinoma (HCC) patients with macrovascular invasion: A pre-specified analysis of the TALENTop study

Background

The TALENTop study (NCT04649489) is aiming to clarify whether hepatic resection may provide additional benefit in HCC patients responding to atezolizumab (atezo) plus bevacizumab (bev).

Methods

Treatment-naïve and potentially resectable HCC patients with macrovascular invasion (MVI) and without extrahepatic metastasis are eligible for this study. Eligible patients receive 3 cycles of atezo/bev and 1 cycle of atezo as primary systemic therapy (induction phase). Patients assessed as partial response (PR) or stable disease (SD) per RECIST v1.1 and considered suitable for R0 hepatic resection are randomized in a 1:1 ratio to either Arm A, hepatic resection followed by atezo/bev for 1 year, or Arm B, continuing atezo/bev therapy. The primary endpoint is the time to treatment failure (tumor recurrence or progression, or death). A pre-specified safety analysis of surgical resection was performed after 10 patients underwent surgery.

Results

From Apr 2021 to May 2022, 107 patients entered induction phase, and 27 were randomized [13 PR and 14 SD]. Of them, 14 patients were randomized to surgery Arm A (10 subjects with liver resection at data cutoff), and 13 patients to Arm B. All grades treatment-related adverse events (AEs) of Arms A and B occurred in 3 (21.4%) and 6 (46.2%) patients, respectively. In Arm A, treatment related grade 3/4 AEs occurred in 3 patient (21.4%) (weight loss, immune-mediated hepatitis, AST/ALT increase). No hemorrhage, thromboembolism or GI perforation events occurred in either arm. Surgical resection was generally safe in the 10 patients. Two experienced postoperative complications (grade IIIa and IVa respectively by Clavien-Dindo criteria). Two post-hepatectomy liver failure occurred (grades A and B respectively by ISGLS criteria). Median post-operative hospital stay was 14 days (range 6-68) and no post-operative (within 30 days) death occurred.

Conclusions

Hepatic resection with peri-operative atezo/bev was safe for HCC patients with MVI so far. Recruitment is ongoing for clarification of treatment efficacy and safety profile.

Clinical trial identification

NCT04649489.

Editorial acknowledgement

Legal entity responsible for the study

Zhongshan Hospital, Fudan University.

Funding

Roche.

Disclosure

H. Sun: Financial Interests, Personal, Invited Speaker: Bayer, BeiGene, Eisai, Hengrui, Innovent, MSD, Roche, TopAlliance. X. Zhu: Financial Interests, Personal, Invited Speaker: Beigene, Eisai, Innovent, MSD, Roche. All other authors have declared no conflicts of interest.