Abstract 283P
Background
Currently, the efficacy of postoperative adjuvant therapy for biliary tract cancer (BTC) is deemed unsatisfactory, necessitating a pursuit of innovative therapeutic strategies. This study aimed to evaluate the effectiveness and safety of tislelizumab in combination with lenvatinib and capecitabine as adjuvant treatment following radical resection of BTC.
Methods
In this prespecified first interim analysis of a phase 2 trial, conducted as an open-label, single-arm study, we recruited patients with BTC after radical surgery in China. All patients received adjuvant tislelizumab (200 mg IV Q3W) plus lenvatinib (8 mg PO QD) and capecitabine (1250 mg/m2 PO BID on days 1-14 of a 21-day cycle) within a period of 4-16 weeks post-surgery. The primary endpoint was 1-year disease-free survival (DFS) rate. Secondary endpoints included DFS, 2-year DFS rate, 1-year and 3-year overall survival (OS) rates, and safety. The first interim analysis for DFS was scheduled based on the availability of data on 1-year DFS rate. The study follow-up is currently ongoing, and no patients are under continued treatment.
Results
From Feb. 24, 2022 to Dec. 31, 2022, a total of 50 eligible patients were enrolled and evaluated for efficacy and safety. As of the cutoff date for this interim analysis on Dec 31, 2023, the median follow-up was 14.37 months (95% CI: 13.82-15.75). The median DFS was 20.23 months (95% CI: 10.84-29.62), accompanied by a 1-year DFS rate of 62.74% (95% CI: 47.45%-74.99%). The median OS has not yet been reached, but the 1-year OS rate was 95.65% (95% CI: 91.15%-97.75%). Ten (20%) patients experienced grade 3 adverse events (AEs), including hand-foot syndrome (6%), elevated bilirubin levels (6%), rash (4%), pulmonary infection (4%), and proteinuria (2%). No serious AEs or treatment-related deaths were observed.
Conclusions
The results of interim analysis suggest promising outcomes and acceptable tolerability of tislelizumab plus lenvatinib and capecitabine for patients with BTC. Further evaluation of DFS and OS with extended follow-up will provide additional insights into the efficacy of this combination in the adjuvant setting for BTC.
Clinical trial identification
NCT05254847.
Legal entity responsible for the study
The authors.
Funding
Beijing Red Lilac Public Welfare Development Center.
Disclosure
All authors have declared no conflicts of interest.