Tislelizumab as Part of a Conversion Therapy Regimen for Potentially Resectable Biliary Tract Cancers

Web Exclusives — November 22, 2022

Although biliary tract cancer (BTC) can only be cured by surgery, this is not an option for all patients. Converting locally unresectable patients to resectable patients with conversion therapy can improve overall survival. One potential conversion therapy regimen includes tislelizumab, an anti–PD-1 monoclonal antibody. The combination of lenvatinib and tislelizumab has demonstrated encouraging antitumor and safety results in patients with advanced hepatocellular carcinoma. This study evaluated a potential role for a combination of lenvatinib, tislelizumab, and gemcitabine/oxaliplatin (GemOx) in potentially resectable BTC.

The combination of therapies was evaluated in a prospective, single-center, single-arm, phase 2 study. To be enrolled, patients had to have potentially resectable, locally advanced BTC and no previous systemic treatment. They also had to be Child-Pugh class A or B and have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1. Dosing was as follows: GemOx followed by intravenous tislelizumab (200 mg every 3 weeks) and lenvatinib (8 mg/kg orally daily) for ≤7 cycles. If at this point the cancer remained unresectable, patients continued to receive tislelizumab and lenvatinib.

The data reported here include evaluations of 25 patients. The median age of the patients was 59.7 years (range, 33-77 years); 44% of the patients were men. All patients had an ECOG PS score of 1, and a large majority (92%) of the patients were Child-Pugh class A. The median tumor size was 5.3 cm (range, 1.57-11.036 cm); 36% of patients had intrahepatic metastases, 12% had extrahepatic metastases, and 60% had lymph node metastases.

The median duration of therapy before surgery was 3.44 cycles (range, 2-8). After treatment, 13 (52%) patients had received R0 resection, 2 (8%) patients received intraoperative radiotherapy, and 1 (4%) patient had complete pathological response. In terms of clinical/pathological outcomes, objective response rate was 56%, disease control rate was 92%, conversion rate was 84%, and surgery rate was 60%. Before treatment, 80% of patients had cancer antigen 19-9 levels >37 U/mL, and after treatment, this was reduced to 60% of patients.

No patients experienced severe complications. Grade 3 treatment-related adverse events included leukopenia, thrombocytopenia (3 patients each), diarrhea, and hypertension (2 patients each).

Based on these results, the authors concluded that the combination of tislelizumab with lenvatinib and GemOx is a promising therapeutic regimen for patients with potentially resectable locally advanced BTC.

Source: Dongming L, Xihao Z, Han M, et al. A single-arm, open-label, phase II study of tislelizumab combined with lenvatinib and GEMOX regimen for conversion therapy of potentially resectable locally advanced biliary tract cancers. Ann Oncol. 2022;33(suppl 7):S570.

Related Items

The Impact of mFOLFOX Chemotherapy in Conjunction with Active Symptom Control on Patient QOL: The ABC-06 Trial
Web Exclusives
Preliminary analyses of patient quality-of-life data from the ABC-06 clinical trial suggest a potentially positive impact of L-folinic acid plus oxaliplatin plus 5-fluorouracil when used in conjunction with active symptom control.
Derazantinib Shows Clinical Efficacy in the Treatment of iCCA in Patients with Genetically Aberrant FGFR2
Web Exclusives
Data from the FIDES-01 clinical trial showed encouraging results for derazantinib as a second-line treatment for patients with intrahepatic cholangiocarcinoma with FGFR2 fusions, mutations, or amplification.
Real-World Evidence for Liquid Biopsy to Identify Molecular Alterations
Web Exclusives
Real-world evidence supports a role for liquid biopsy in identifying molecular alterations, offering personalized treatment options.
FGFR Inhibitor RLY-4008 Shows Promise in Treating Metastatic CCA
Web Exclusives
Early data from the ReFocus trial indicated that the highly selective FGFR2 inhibitor RLY-4008 may be an effective new treatment for cholangiocarcinoma in patients with FGFR2 fusions or rearrangements.
Nanoliposomal Irinotecan Combination Therapy Falls Short in Metastatic BTC
Web Exclusives
The NALIRICC study compared the efficacy of nanoliposomal irinotecan plus 5-fluorouracil (5-FU) plus leucovorin (LV) with 5-FU plus LV on progression-free and overall survival in patients with biliary tract cancer.
Additional 6-Month Follow-up from the TOPAZ-1 Study Comparing Durvalumab with Placebo plus Gem/Cis in Patients with Advanced BTC
Web Exclusives
Updated overall survival (OS) and safety data from the TOPAZ-1 study revealed improved median OS for the full patient population as well as subgroup analyses and an adverse event profile consistent with previously reported data.
Immune-Related Adverse Events in the TOPAZ-1 Study of Durvalumab or Placebo plus GemCis in Advanced BTC
Web Exclusives
Analysis of the safety population in the TOPAZ-1 trial in patients with biliary tract cancer revealed that immune-related adverse events were more common in the durvalumab arm, had a variable time to onset, and were associated with improved overall survival.
CCA Summit Live from ESMO 2022
By Juan W. Valle, MB ChB, MSc, FRCP
On September 21, 2022, I presented an overview of key abstracts on biliary tract cancer (BTC) presented at the 2022 annual meeting of the European Society for Medical Oncology. In addition, I provided my perspective on the impact of the data on the management of patients with BTC.
Key Abstracts Presented at the European Society for Medical Oncology (ESMO) 2021 Annual Meeting
By Richard Kim, MD
Richard Kim, MD, from the Moffitt Cancer Center, University of South Florida College of Medicine, provides expert commentary on key abstracts and posters presented at the 2021 annual meeting of the European Society for Medical Oncology. Dr Kim will highlight new data from 11 presentations on interventional modalities for patients with cholangiocarcinoma.
Futibatinib Safe and Effective in Patients with Advanced or Metastatic Intrahepatic Cholangiocarcinoma and FGFR2 Fusions
October 2020, Vol 1, No 2
Two phase 2 studies of futibatinib, a highly selective irreversible fibroblast growth factor receptor (FGFR)1-4 inhibitor, analyzed data from the FOENIX-CCA2 clinical trial and were presented at the 2020 virtual meeting of the European Society for Medical Oncology (ESMO).

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: