1 Department of Medicine, University of Hong Kong, Hong Kong, China. Electronic address: firstname.lastname@example.org.
2 Graduate Institute of Oncology, College of Medicine, National Taiwan University and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
3 Division of Medical Oncology, Seoul National University, Seoul, South Korea.
4 Division of Medical Oncology, National Cancer Centre, Singapore.
5 Department of Oncology, Asan Medical Center, University of Ulsan, Seoul, South Korea.
6 Division of Hematology and Oncology, Chang Gung Memorial Hospital, Taipei, Taiwan.
7 Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.
8 Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.
9 Department of Medical Oncology, OncoCare Cancer Centre, Singapore.
10 Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
11 Department of Medicine, Kurume University Hospital, Fukuoka, Japan.
12 Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.
13 Deparment of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
14 Bristol-Myers Squibb, Princeton, NJ, USA.
15 Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
BACKGROUND & AIMS:
Nivolumab, an immune checkpoint inhibitor, is approved in several countries to treat sorafenib-experienced patients with hepatocellular carcinoma (HCC), based on results from CheckMate 040 (NCT01658878). Marked differences exist in HCC clinical presentation, etiology, treatment patterns, and outcomes across regions. This analysis assessed the safety and efficacy of nivolumab in the Asian cohort of CheckMate 040.
CheckMate 040 is an international, multicenter, open-label, phase I/II study of nivolumab in adults with advanced HCC, regardless of etiology, not amenable to curative resection or local treatment, with/without prior sorafenib treatment. This analysis included all sorafenib-experienced patients in the intent-to-treat (ITT) overall population and Asian cohort. The analysis cutoff date was March 2018.
There were 182 and 85 patients in the ITT population and Asian cohort, respectively. In both populations, most patients were >60 years old, had Barcelona Clinic Liver Cancer stage C disease, and had received prior systemic therapy. A higher percentage of Asian patients had HBV infections, extrahepatic metastases, and prior therapies. Median follow-up was 31.6 and 31.3 months for the ITT and Asian patients, respectively. Objective response rates (ORRs) were 14% and 15% in the ITT population and Asian cohort, respectively. In the Asian cohort, uninfected, HBV-infected, and HCV-infected patients had ORRs of 21%, 13%, and 14%, respectively. Median duration of response was longer in the ITT (19.4months) vs. Asian patients (9.7months). Median overall survival was similar between the ITT (15.1months) and Asian patients (14.9months), and unaffected by etiology in Asian patients. Nivolumab safety profile was similar and manageable across both populations.
Nivolumab safety and efficacy is comparable between sorafenib-experienced ITT and Asian patients.
The CheckMate 040 study evaluated the safety and efficacy of nivolumab in patients with advanced hepatocellular carcinoma (HCC) who were refractory to prior sorafenib or chemotherapy. This sub-analysis of the data showed that treatment responses and safety in patients in Asia were similar to that of the overall treatment population, providing support for nivolumab as a treatment option for these patients.