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Real-world Experience with Immunotherapy:
A Multidisciplinary Approach for Patients with HCC

Hepatocellular carcinoma (HCC) is the most common primary liver malignancy and is the second
most frequent cause of cancer-related death worldwide. Unfortunately, the majority of patients
diagnosed with HCC present with advanced disease. Sorafenib is an oral multikinase inhibitor and it

became the standard-of-care (SOC) systemic therapy for advanced HCC with median survival ranging
from 6.5 to 10.7 months since 2008.

Nivolumab, a programmed cell death-1 (PD-1) checkpoint inhibitor, is the first approved Immune

checkpoint inhibitor (ICI) for sorafenib-treated patients with HCC based on results from CheckMate
040. Checkmate 040 is the first phase I/II study showed nivolumab improved survival to 15.6
months and response to 14.5% for sorafenib experienced patients. With the encouraging outcome
for the strong unmet clinical needs, nivolumab was approved for HCC second line treatment by FDA

and TFDA which resulted in more real-word data (RWD) with nivolumab in HCC patients.

Fessas P et al. reported an RWD enrolled 219 patients from Asia, North America, and Europe with a
22.4% objective response rate (ORR) and a 12.2 months mOS. For Child-Pugh A patients, the mOS

was 16.3 months which is comparable to CheckMate 040. Two Korea RWD enrolled 33 and 261
patients with HCC also showed a 18% and 15.3% ORR respectively which are also comparable to the
result from Opdivo pivotal trial. Taiwan data from NTUH and TPVGH also reported a 25-35% ORR
and the outcome was also comparable to CheckMate 040 data. In conclusion, Nivolumab

demonstrated clinically meaningful benefit in patients with HCC in Checkmate 040 study and
worldwide RWD showed a comparable benefit to patient with advanced HCC