Abstract 2421
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.
Resources from the same session
4900 - Molecular profiling and prognostic significance of TP53 mutations in Diffuse Large B Cell Lymphoma: identifying a high-risk subgroup
Presenter: Yuan-Kai Shi
Session: Poster Display session 3
Resources:
Abstract
3809 - Differential expression of various miRNAs in Pediatric Cytogenetically Normal Acute Myeloid Leukemia (CN-AML)
Presenter: Vikas Gaur
Session: Poster Display session 3
Resources:
Abstract
4750 - Circulating tumour cells in head and neck and non-small cell lung cancer
Presenter: Kenneth O'Byrne
Session: Poster Display session 3
Resources:
Abstract
3704 - OX40/OX40L protein expression in Non-small cell lung cancer and its role in clinical outcome and relationships with other immune biomarkers
Presenter: Xiaoshen Zhang
Session: Poster Display session 3
Resources:
Abstract
2235 - Effect of Serum Survivin on Survival among Non-Small Cell Lung Cancer Patients; NCI Experience
Presenter: Reham Rashed
Session: Poster Display session 3
Resources:
Abstract
2788 - Enhanced performance of prognostic estimation from TCGA RNAseq data using transfer learning.
Presenter: Helene Vanacker
Session: Poster Display session 3
Resources:
Abstract
4689 - Analysis of Circulating Tumor DNA for Early Relapse Detection in Stage III Colorectal Cancer After Adjuvant Chemotherapy
Presenter: Samuel Jacobs
Session: Poster Display session 3
Resources:
Abstract
1454 - Ascites-derived circulating microRNAs as potential diagnostic biomarkers of gastric cancer-associated malignant ascites
Presenter: Hye Sook Han
Session: Poster Display session 3
Resources:
Abstract
5574 - Results from TRIO030, a Pre-Surgical Tissue-Acquisition Study to Evaluate Molecular Alterations in Human Breast Cancer Tissue Following Short-Term Exposure to the Androgen Receptor Antagonist Darolutamide
Presenter: Hsiao-Wang Chen
Session: Poster Display session 3
Resources:
Abstract
1787 - JMJD2A is a novel epigenetic factor of chemotherapeutic susceptibility in gastric cancer
Presenter: Yasushi Sato
Session: Poster Display session 3
Resources:
Abstract