Immunotherapy, alongside gemcitabine-based chemotherapy, is now a standard first-line treatment for patients with advanced biliary tract cancer (BTC). Furthermore, previous small studies have suggested that immune checkpoint inhibitors, such as programmed cell death protein 1 and programmed death-ligand 1, combined with lenvatinib and chemotherapy, demonstrate high antitumor activity in patients with BTC.
A recent retrospective study, presented at the 2025 ASCO Gastrointestinal Cancers Symposium, explored the effectiveness and safety of combining durvalumab and gemcitabine-based chemotherapy with lenvatinib for the treatment of advanced BTC. The study included patients with advanced BTC who received durvalumab combined with gemcitabine-based chemotherapy with or without lenvatinib between January 2021 and September 2024. Endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety.
The study included a total of 30 patients. Fourteen (46.7%) of the 30 patients received durvalumab with lenvatinib plus chemotherapy. For all patients, the median OS was 9.5 months (95% confidence interval [CI], 5.0-14.0), and the median PFS was 5.9 months (95% CI, 4.5-7.4). The ORR was 43.4%, and the disease control rate (DCR) was 76.7%. Patients receiving lenvatinib experienced a longer median PFS (6.5 months) compared with those not receiving lenvatinib (4.6 months), although the P value was not significant (P=.85). However, the median OS was slightly shorter in the lenvatinib group (9.0 months) compared with the non-lenvatinib group (9.5 months) (P=.915). The ORR and DCR were higher in patients receiving lenvatinib (57.1% and 92.9%, respectively) compared with the non-lenvatinib group (31.2% and 62.5%, respectively). In those who received lenvatinib, 1 patient had significantly reduced lesion size and underwent radical surgical resection. All patients experienced adverse events (AEs), with the most common in the intent-to-treat population being anemia (63.3%), thrombocytopenia (56.6%), and neutropenia (46.7%). The addition of lenvatinib did not increase the risk of AEs.
The combination of durvalumab and gemcitabine-based chemotherapy, with or without lenvatinib, appears to be effective and safe for the treatment of patients with advanced BTC. The addition of lenvatinib improved ORR, but did not significantly prolong OS in this study. Further research with larger cohorts is needed to better understand the role of lenvatinib in this treatment regimen.
Ding Q, Yu H, Wang G, et al. Efficacy and safety of durvalumab and gemcitabine-based chemotherapy combined with or without lenvatinib in advanced biliary tract cancer. Presented at: ASCO Gastrointestinal Cancers Symposium. January 23-25, 2025; San Francisco, CA; Virtual. Poster C21.
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