Efficacy and safety of pembrolizumab, lenvatinib, and reduced-dose gemcitabine/oxaliplatin as initial treatment for advanced biliary tract cancer: a multicenter, single-arm, prospective, phase II stud

3 months ago

Study evaluates pembrolizumab, lenvatinib, and reduced-dose gemcitabine/oxaliplatin (GEMOX) as first-line therapy for advanced biliary tract cancer (BTC).
60 patients with unresectable or metastatic BTC were treated with the combination therapy, followed by maintenance pembrolizumab and lenvatinib.
Primary endpoint was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), and safety.
Results showed an ORR of 55.0% (complete response 5.0%, partial response 50.0%) and disease control rate of 93.3%.
Median PFS was 12.5 months, and median OS was 19.5 months.
Elevated baseline CA19-9 and carcinoembryonic antigen levels were associated with poorer outcomes.
Treatment-related adverse events (AEs) were mostly grades 1-2, with grade 3-4 AEs in 65% of patients and no treatment-related deaths.
Immune-related AEs occurred in 11.7% of patients and were predominantly mild.
The combination showed promising efficacy and manageable toxicity, suggesting chemotherapy de-escalation may optimize efficacy-toxicity balance.

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