Phase 2 study of adjuvant benmelstobart plus anlotinib after resection of hepatocellular carcinoma in patients with high recurrence risk

The multicenter phase 2 ALTER-H006 trial in China evaluated adjuvant benmelstobart (anti-PD-L1) plus anlotinib (multi-targeted TKI) after resection of hepatocellular carcinoma (HCC) in patients with high risk of recurrence: ≥ 4 tumors, portal vein tumor thrombus (Vp1/2) or hepatic vein thrombus (Vv1/2). Primary endpoint was 1-year recurrence-free survival (RFS) rate. Among 37 patients with mediane 12.6 months of follow-up, 1-year RFS rate was 59.7%, with median RFS 15.6 months. Among Vp1/2 and Vv1/2 patients, median RFS was18.2 months and not reached, respectively. The longest recurrence-free duration is 25.9 months. Median overall survival was not reached, with 1-year OS rate of 91.7%. Grade 3 or 4 treatment-related adverse events occurred in 45.9% of patients, most commonly hypertension. There were no grade 5 TRAEs. The authors conclude that adjuvant benmelstobart plus anlotinib is a feasible treatment option for HCC patients with high risk of recurrence.