Abstract 141P
Background
Immunotherapy combined with targeted therapy have become recommended regimens for advanced HCC. Considering that patients are strictly screened in clinical trials, while the efficacy and safety in the real-world are affected by various factors, real-world data of anti-PD-1 antibody combined with targeted therapy is urgently needed.
Methods
In this non-interventional study, patients with histologically or clinically confirmed unresectable HCC with BCLC Stage B/C who were planning to receive or have already received tislelizumab combination therapy were enrolled. Treatment included tislelizumab (200 mg IV Q3W) plus a tyrosine kinase inhibitor (TKI) or VEGFR2 inhibitor selected from lenvatinib (12mg/8mg PO QD), sorafenib (400 mg PO BID) and apatinib (750 mg QD). During the treatment, patients assessed as eligible for resection would undergo surgery. The primary endpoint was ORR assessed by RECIST 1.1. Secondary endpoints included DCR, PFS, OS and safety.
Results
From March 2020 to March 2021, 44 patients were enrolled with a median age of 55 (range: 31-71) years old. Among them, 37 (84.1%) patients were male, 13 (29.5%) patients had extrahepatic metastase. Child-Pugh class A (n=42,95.5%) or B (n=2, 4.5%); ECOG PS 0 (n=24, 54.5%) or 1 (n=20, 45.5%). Patients received tislelizumb plus lenvatinib (n=33; 3 of which also received TACE), or plus sorafenib (n=7), or plus apatinib (n=3). The ORR and DCR were 47.7% (21/44) and 84.1% (37/44), respectively. 15 (34.1%) patients were evaluated as operable after the combination treatment; 3 of them achieved pathological complete response (pCR). No severe postoperative complications were observed. Grade 3 or higher AEs were mainly hypertension (11.4%), rash (9.1%), proteinuria (6.8%), thrombocytopenia (6.8%), hand-foot syndrome (6.8%) and febrile neutropenia (6.8%).
Conclusions
In the real-world setting, tislelizumab plus targeted therapy shows favorable efficacy with reasonable tolerability as 1L treatment options for patients with unresectable HCC. The combination may also provide an opportunity for curative resection.
Clinical trial identification
NCT04996459. Enrollment of this study began in March 2020.
Legal entity responsible for the study
Lu Wang.
Funding
Beijing Medical Award Foundation.
Disclosure
All authors have declared no conflicts of interest.