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Ref Type Journal Article
PMID (33139266)
Authors Lee DW, Cho EJ, Lee JH, Yu SJ, Kim YJ, Yoon JH, Kim TY, Han SW, Oh DY, Im SA, Kim TY, Lee Y, Kim H, Lee KH
Title Phase II study of Avelumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib.
Journal Vol Issue Date Pages Journal Short Title
Clinical cancer research : an official journal of the American Association for Cancer Research 2020 Nov 02 713-718 Clin Cancer Res
URL
Abstract Text This study investigated the efficacy and safety of avelumab, an anti-PD-L1 antibody, in patients with advanced hepatocellular carcinoma previously treated with sorafenib (NCT03389126).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.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, 3 (10.0%) partial response, and 19 (63.3%) 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 7 grade 3 adverse events and no grade 4 adverse events.Avelumab showed moderate efficacy and was well tolerated in advanced hepatocellular carcinoma previously treated with sorafenib.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References