949P - Update results of ALTER-H006: A phase II study of TQB2450 plus anlotinib as adjuvant therapy in hepatocellular carcinoma (HCC) with high risk of recurrence after surgical resection

Background

Hepatocellular carcinoma (HCC) represents as one of the leading cause of cancer-related deaths in many parts of the world. Surgical resection remains as the mainstay of curative treatment option. However, the recurrence rate after surgical resection could be high especially in patients with CNLC stage IIb (tumor number > 3) and IIIa (vascular invasion). Herein we evaluated the efficacy and safety of the anti-angiogenic tyrosine kinase inhibitor, anlotinib, plus TQB2450, a novel programmed death-ligand 1 (PD-L1) inhibitor as an adjuvant treatment for HCC with high risk of recurrence after surgical resection.

Methods

This study enrolled patients diagnosed with HCC, whose age were 18-75, with ECOG 0-1, 4∼8 weeks after R0 resection with any of the following high-risk factors for recurrence: a) tumor nodules ≥4; b) portal vein tumor thrombus: vp1 or vp2; c) hepatic vein tumor thrombus: vv1 or vv2. Patients enrolled received anlotinib (12 mg, p.o., qd, d1-14, q3w) plus TQB2450 (1200 mg, i.v., d1, q3w) until disease recurrence or unacceptable toxicity or up to 18 cycles, whichever occurred first. The primary endpoint was 1-year recurrence-free survival (RFS) rate. Secondary endpoints included RFS, 1-year overall survival (OS) rate, and safety.

Results

Between January 2022 and April 2024, a total of 38 pts were enrolled and 37 pts included in per-protocol set analysis. The 37 pts were predominantly male (95%, n = 35), and the median age was 56.5 years (range: 33-75). 17 pts (46%) had CNLC Stage IIb and 20 (54%) had CNLC Stage IIIa HCC. According to RECIST 1.1, out of 37 pts, 24 showed no recurrence, 11 relapsed, 1 dropped out and 1 discontinued due to serious adverse events. The 1-year RFS rate was 53.03% (95%CI: 28.61-72.50) and the median RFS was 12.55 months (95%CI: 5.50 -19.60). 31 of 38 pts (89.7%) experienced treatment-related adverse events (TRAEs). The common grade ≥3 treatment-emergent adverse events were hypertension (23.7%).

Conclusions

The present study indicated that anlotinib plus TQB2450 as adjuvant treatment for HCC with high risk of recurrence after surgical resection exhibited promising efficacy and tolerable safety profile.

Clinical trial identification

NCT05111366.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Chia Tai Tian Qing Pharmaceutical Group Co. Ltd. (CTTQ).

Disclosure

All authors have declared no conflicts of interest.