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      저자 : ( Akhil Chopra ) (검색결과 1 건)
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      • Hepatic Safety and Biomarker Assessments in Sorafenib-Experienced Patients with Advanced Hepatocellular Carcinoma Treated with Nivolumab in the CheckMate-040 Study

        ( Thomas Yau ),( Tim Meyer ),( Ignacio Melero ),( Chiun Hsu ),( Masa-toshi Kudo ),( Su-pin Choo ),( Jorg Trojan ),( Theodore H. Welling ),( Yoon-koo Kang ),( Winnie Yeo ),( Akhil Chopra ),( Adyb Baaki 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

        Aims: Nivolumab (NIVO) is a fully human anti-PD-1 IgG4 mAb that demonstrated durable responses, manageable safety, and long-term survival in pts with advanced HCC (aHCC) in CheckMate-040 (El-Khoueiry AB et al. Lancet 2017). Here we present updated hepatic safety and biomarker analyses in sorafenib-experienced (sor-exp) pts in CheckMate-040. Methods: Sor-exp pts with or without chronic viral hepatitis received NIVO 3 mg/kg Q2W. Primary endpoint was objective response rate (ORR) reported by blinded independent central review using RECIST v1.1. Secondary endpoints included overall survival (OS), disease control rate (DCR), and safety. Exploratory analyses of on-treatment HCV and HBV viral kinetics and alpha-fetoprotein (AFP) levels were performed. Results: Median duration of follow-up was 14.9 mo. Baseline Child-Pugh scores of 5 or 6 and extrahepatic metastases were observed in 99% and 71% of pts, respectively. The ORR with NIVO was 14%; the DCR was 56%; median OS was 15.6 mo. Any-grade and grade 3-4 hepatic treatment-related AEs (TRAEs) occurred in 12 (8%) and 5 (3%) pts, respectively; 100% of grade 3-4 hepatic TRAEs resolved. Frequencies of grade 3-4 treatment-related ALT/AST elevations were 2%-3%. No drug-related deaths due to hepatic AEs occurred, and no new safety signals were observed. AFP levels at baseline were not associated with response; however, AFP levels in responders appeared to decrease on treatment. Updated data will be presented. Conclusions: NIVO demonstrated long-term survival and objective responses across etiologies and manageable overall and hepatic safety profile in aHCC. Responses occurred irrespective of baseline AFP levels, and AFP declines were associated with response.

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