Efficacy and Safety of Nivolumab in Asian Patients With Advanced Hepatocellular Carcinoma (HCC): Subanalysis of the CheckMate 040 Study
Refereed conference paper presented and published in conference proceedings


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AbstractBackground: Many patients with advanced HCC progress on sorafenib therapy. Nivolumab is a fully human anti–programmed death-1 (PD-1) immunoglobulin G4 monoclonal antibody (IgG4 mAb) that demonstrated durable responses and long-term survival in patients with advanced HCC in the CheckMate-040 study (El-Khoueiry AB, Sangro B, et al. Lancet 2017). Here we present survival, durability of response, and safety data in Asian patients with advanced HCC in CheckMate-040.

Method: Patients naive to or previously treated with sorafenib received nivolumab in phase 1/2 dose-escalation (ESC; 0.1–10 mg/ kg) and expansion (EXP; 3 mg/kg) cohorts every 2 weeks regardless of programmed death ligand 1 (PD-L1) status. Primary endpoints were safety and tolerability (in ESC) and objective response rate (ORR) reported by blinded independent central review using RECIST v1.1 (in EXP). Secondary endpoints included duration of response (DOR), disease control rate (DCR), and overall survival.

Result: Asian patients (N = 107) from Hong Kong (n = 25), Japan (n = 32), Korea (n = 13), Singapore (n = 15), and Taiwan (n = 22) were included in the analysis; median follow-up was 19.2 months. Median age was 62 years, and 99% had Child-Pugh scores of 5–6. Overall, 18% and 50% of patients were infected with hepatitis C or B virus, respectively; 32% were uninfected. The ORR was 15% (Table), and the DCR was 48%; the median DOR was 13.8 months; 6 of 16 responses (38%) were ongoing. In sorafenib-experienced patients (n = 85), the ORR was 15%, and the DCR was 49%. Median overall survival and overall survival rates in Asian sorafenib-experienced patients<65 years and >65 years of age were comparable. Overall, treatment-related AEs (TRAEs; any grade) and grade 3–4 TRAEs occurred in 75% and 11% of patients, respectively; rates of grade 3–4 ALT and AST elevations were 1%–2%. Additional efficacy and safety data will be presented.

Conclusion: Nivolumab demonstrated durable responses and manageable safety in Asian patients with advanced HCC with or without chronic viral hepatitis.
All Author(s) ListAmy Ma, Su-Pin Choo, Chiun Hsu, Yoon-Koo Kang, Ming-Mo Hou, Winnie Yeo, Kazushi Numata, Akhil Chopra, Adyb Baakili, Christine dela Cruz, Huanyu Zhao, Masatoshi Kudo
Name of Conference27th Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL)
Start Date of Conference14/03/2018
End Date of Conference18/03/2018
Place of ConferenceNew Delhi
Country/Region of ConferenceIndia
Proceedings TitleHepatology International
Year2018
Month3
Volume Number12
Issue NumberSuppl 2
PublisherSpringer
PagesS217 - S217
ISSN1936-0533
eISSN1936-0541
LanguagesEnglish-United Kingdom
KeywordsAdvanced Hepatocellular Carcinoma, Nivolumab

Last updated on 2018-22-11 at 11:10