Abstract 172P
Background
The BGB-A317-211 study demonstrated the safety and efficacy of tislelizumab (PD-1 antibody) combined with tyrosine kinase inhibitors (TKIs) as first-line treatment in patients (pts) with uHCC. And the EMERALD-1 study results showed that immunotherapy combined with anti-VEGF therapy and transarterial chemoembolization (TACE) significantly improved PFS in uHCC with manageable safety. The purpose of this study was to evaluate the efficacy and safety of TACE combined with tislelizumab and TKIs as conversion therapy in pts with initial uHCC.
Methods
This was a single-center, single-arm, phase II clinical study (NCT06232759). Eligible pts were treatment-naïve pts with uHCC (oncologic unresectable or insufficient liver volume after R0 resection). Enrolled pts received TACE combined with tislelizumab (200mg, IV, q3w) and TKIs. The primary end point was surgical conversion rate. Secondary end points were objective response rate (ORR), disease control rate (DCR), pathologic response, progression-free survival (PFS) and safety.
Results
At data cutoff on Nov 2023, a total of 51 uHCC pts were included, including 12 pts BCLC-A stage, 24 pts B stage and 15 pts C stage. ORR and DCR were 80.4% and 90.2% (15 pts CR, 26 pts PR) per mRECIST. 49.0% (25/51) pts met the criteria for successful conversion and 45.1% (23/51) received surgical resection finally. 12 pts had pathological complete response and 19 pts achieved major pathological response (proportion of pathological residual tumor ≤ 30%). The median postoperative follow-up time was 10.0 months, and the mPFS was 18.7 months. No serious complications occurred during perioperative period. Most treatment-related adverse events (TRAEs) were grade 1-2, 10 pts (19.6%) had grade 3 TRAEs. The most common were hand-foot syndrome, hypertension and transaminases elevation. All TRAEs were expected and manageable, and no treatment-related deaths occurred.
Conclusions
TACE combined with tislelizumab and TKI demonstrate promising efficacy and manageable safety in uHCC, which maybe a potential regimen option as conversion therapy.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.