Nivolumab vs. Sorafenib for the treatment of advanced hepatocellular carcinoma

Nivolumab vs. Sorafenib for the treatment of advanced hepatocellular carcinoma

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual (1-4 July), the long-term findings from the CheckMate 459 phase III study in Spain concluded that for the management of advanced hepatocellular carcinoma (HCC), nivolumab as a first-line treatment did not show statistically longer overall survival (OS) at a minimum follow-up of 33.6 months in comparison with monotherapy with sorafenib.

Compared with sorafenib, nivolumab demonstrated improved preservation of liver function over time and a more favorable and manageable safety profile that depicted consistency with the prior reports. No novel or unpredicted safety signals were witnessed.

Treatment with multitargeted kinase inhibitors or immune checkpoint inhibitor-based combination therapy may be utilized for patients with advanced HCC who are not amenable to surgical resection or locoregional therapy. Although sorafenib is utilized as first-line therapy in that setting, it offers only a moderate survival benefit. Despite currently authorized first-line treatments for advanced HCC, extending survival while enhancing treatment tolerability remains an unfulfilled medical requisition.

A phase III trial (CheckMate 459) was therefore conducted to compare first-line treatment with nivolumab vs sorafenib in 743 systemic therapy-naive patients (age: at least 18 years old) having advanced HCC and Child-Pugh A liver function. At ESMO 2019 Congress in Barcelona, the initial safety and efficacy data were previously presented by Yau who reported that the protocol-defined statistical significance threshold for OS was not fulfilled, although nivolumab demonstrated clinical benefit.

The ESMO World Congress on Gastrointestinal Cancer 2020 Virtual displayed the findings of long-term clinical follow-up. Participants were randomized 1:1 to either sorafenib (n = 372) group or nivolumab (n = 371) group. OS was the primary outcome to be ascertained.

Objective response rate and progression-free survival by blinded independent central review per RECIST (Response evaluation criteria in solid tumors) v1.1, safety, and efficacy by programmed death-ligand 1 (PD-L1) tumor cell expression were the secondary outcome measures. With a minimum follow-up of 33.6 months, nivolumab showed a longer median OS and greater 33-month OS rates when compared to sorafenib as shown in the following table:

Nivolumab group

Sorafenib group

Median OS

16.4 months

14.8 months

33-month OS rates

29 %

21 %

Regardless of baseline PD-L1 expression, a persistent benefit was witnessed with nivolumab. In patients having PD-L1 ≥1%, the median OS was found to be longer with nivolumab in comparison with sorafenib. Among patients with hepatitis C virus (HCV) and hepatitis B virus (HBV) etiology, the median OS was numerically longer with nivolumab compared with sorafenib as shown in the following table:

Nivolumab group

Sorafenib group

Median OS in patients having PD-L1 ≥1%

16.1 months

8.6 months

Median OS in patients with HCV

17.5 months

12.7 months

Median OS in patients with HBV

16.1 months

10.4 months

Compared to sorafenib, a greater liver function preservation over time was shown by nivolumab as depicted by albumin-bilirubin levels and Child-Pugh scores. Nivolumab demonstrated a more favorable and acceptable safety profile compared with sorafenib. The number of patients given subsequent therapy with immune checkpoint inhibitors is shown in the following table:

Nivolumab group

Sorafenib group

Number of patients receiving subsequent treatment with immune checkpoint inhibitor

7 (2%)

77 (21%)

Number of patients witnessing grade 3-4 treatment-related adverse events

82 (22.3%)

180 (49.6%)

Thus, nivolumab may be considered as a vital frontline standard of care for patients having advanced HCC.

Source

ESMO

Link:

https://www.esmo.org/oncology-news/nivolumab-vs-sorafenib-in-first-line-treatment-of-advanced-hepatocellular-carcinoma

Original title of the article

NIVOLUMAB VS SORAFENIB IN FIRST-LINE TREATMENT OF ADVANCED HEPATOCELLULAR CARCINOMA

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