2421 - Lenvatinib plus PD-1 blockade in advanced bile tract carcinoma.

Background

Co-inhibiting angiogenesis and PD-1/PD-L1 is a promising regimen for several solid tumours; however, its role in bile tract carcinoma (BTC) remains unclear. We sought to investigate the antitumour efficacy and toxicity of lenvatinib (an oral anti-angiogenesis drug) plus PD-1 blockade in patients with advanced BTC.

Methods

A retrospective cohort study involved patients with advanced BTC who have treated with lenvatinib plus PD-1 blockade. The PD-1 inhibitors only included pembrolizumab and nivolumab. The primary outcomes of this study were the objective response rate (ORR) and progression-free survival (PFS). Biomarkers, including PD-L1 expression, tumour mutational burden (TMB) and genetic alterations, were analysed.

Results

In total, 56 patients (29 with lenvatinib plus nivolumab, 27 with lenvatinib plus pembrolizumab) were enrolled. The ORR was 30.4%, the disease control rate was 85.7%, and the clinical benefit rate was 50%. The median PFS was 5.0 months (95% CI: 4.0-6.0), and the median overall survival was 11.0 months (95% CI: 6.6-15.4). For tolerability, 96.4% of the patients had adverse events (AEs), but only 19.6% of the patients experienced grade-3 AEs without grade-4/5 AEs occurring. Fatigue, hypertension and hypothyroidism were the most common AEs. Moreover, PD-L1 positive expression had higher ORR and longer PFS, while TMB was not correlated with the response and survival outcomes. Further analysis of efficacy-related factors demonstrated that patients with resected BTC could obtain longer OS.

Conclusions

Lenvatinib plus PD-1 inhibitor presents an effective and safe strategy in patients with advanced BTC, especially those with PD-L1 positive expression and prior surgical resection.

Clinical trial identification

NCT03892577.

Editorial acknowledgement

Milind Javle.

Legal entity responsible for the study

The protocol of this study was compliant with the principles of the Declaration of Helsinki and was also approved by the institutional review board and ethics committee of PUMCH.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.