Related Experiment Video
Updated: Dec 2, 2025
Y-90 Radioembolization and PD-1 Inhibitor as Neoadjuvant Treatment in Hepatocellular Carcinoma
Published on: May 24, 2024
Phase II Study of Avelumab in Patients with Advanced Hepatocellular Carcinoma Previously Treated with Sorafenib
Dae-Won Lee1, Eun Ju Cho1,2, Jeong-Hoon Lee1,2
1Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Purpose:
This study investigated the efficacy and safety of avelumab, an anti-programmed death ligand 1 (PD-L1) antibody, in patients with advanced hepatocellular carcinoma previously treated with sorafenib (NCT03389126).
Patients And Methods:
This is a single-arm, single center, phase II trial. Patients with Child-Pugh A score who had at least one measurable lesion were enrolled. Intravenous avelumab 10 mg/kg every 2 weeks was given until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to RECIST v1.1. Secondary endpoints included time to progression (TTP), overall survival (OS), disease control rate (DCR), and safety.
Results:
A total of 30 patients were enrolled. After a median follow-up of 13.9 months, 27 progression events and 20 death events occurred. There was no complete response, three (10.0%) partial responses, and 19 patients (63.3%) with stable disease. ORR was 10.0% and DCR was 73.3%. The median TTP and OS was 4.4 and 14.2 months, respectively. PD-L1 expression did not affect avelumab response. Prior duration of sorafenib treatment, when dichotomized by the median 2.7 months, was associated with treatment outcome. TTP (6.5 vs. 1.8 months, P = 0.007) and OS (19.0 vs. 7.8 months, P = 0.006) were superior in patients with longer sorafenib duration. There was tendency of higher ORR (20.0% vs. 0.0%, P = 0.22) in those with longer sorafenib duration. Avelumab was well tolerated with seven grade 3 adverse events and no grade 4 adverse events.
Conclusions:
Avelumab showed moderate efficacy and was well tolerated in advanced hepatocellular carcinoma previously treated with sorafenib.
Insights
Avelumab demonstrated moderate efficacy in advanced liver cancer patients previously treated with sorafenib. Longer sorafenib treatment duration correlated with improved outcomes and survival for hepatocellular carcinoma patients receiving avelumab.
Area of Science:
- Oncology
- Immunotherapy
- Hepatocellular Carcinoma Research
Background:
- Advanced hepatocellular carcinoma (HCC) presents a significant clinical challenge, particularly after failure of first-line therapies like sorafenib.
- Understanding the efficacy of novel agents in the second-line setting is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the efficacy and safety of avelumab, an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with advanced HCC who progressed on sorafenib.
- To determine the objective response rate (ORR), time to progression (TTP), overall survival (OS), and disease control rate (DCR) of avelumab in this patient population.
Main Methods:
- A single-arm, single-center, phase II clinical trial enrolled 30 patients with advanced HCC and Child-Pugh A score previously treated with sorafenib.
- Patients received intravenous avelumab (10 mg/kg) every two weeks until disease progression or unacceptable toxicity.
- Primary endpoint was ORR by RECIST v1.1; secondary endpoints included TTP, OS, DCR, and safety assessments.
Main Results:
- The objective response rate (ORR) was 10.0% (3/30), with a disease control rate (DCR) of 73.3% (22/30).
- Median time to progression (TTP) was 4.4 months and median overall survival (OS) was 14.2 months.
- Longer prior sorafenib treatment duration (≥2.7 months) was associated with significantly improved TTP (6.5 vs. 1.8 months) and OS (19.0 vs. 7.8 months).
- Avelumab was well-tolerated, with only grade 3 adverse events observed and no grade 4 events.
Conclusions:
- Avelumab demonstrated moderate efficacy and a favorable safety profile in advanced HCC patients previously treated with sorafenib.
- Prior duration of sorafenib therapy is a potential predictive biomarker for response to avelumab in advanced HCC.
- Further investigation into predictive factors for immunotherapy response in HCC is warranted.
More Related Videos
06:38An Oncogenic Hepatocyte-Induced Orthotopic Mouse Model of Hepatocellular Cancer Arising in the Setting of Hepatic Inflammation and Fibrosis
Published on: September 12, 2019
05:56Evaluation of the Feasibility, Safety, and Accuracy of an Intraoperative High-intensity Focused Ultrasound Device for Treating Liver Metastases
Published on: January 9, 2019
Related Concept Videos
02:56Treatment Resistant Cancers
02:57Targeted Cancer Therapies
There are several types of targeted therapies against...