Donafenib in hepatocellular carcinoma

Area of Science:

• Hepatology and Oncology
• Drug Development
• Clinical Trials

Background:

• Hepatocellular carcinoma (HCC) presents a significant global health challenge.
• Existing treatments like sorafenib have limitations in tolerability, leading to therapy discontinuation.
• Donafenib offers a novel therapeutic approach for unresectable HCC.

Approach:

• A multicenter, randomized, controlled phase II-III trial (ZGDH3) evaluated donafenib against sorafenib.
• Donafenib is a deuterated form of sorafenib, designed for enhanced bioavailability.
• The study assessed overall survival, safety, and tolerability as primary endpoints.

Key Points:

• Donafenib demonstrated superior overall survival compared to sorafenib in HCC patients.
• The drug exhibited a favorable safety profile and improved tolerability.
• Donafenib received approval in China in 2021 as a first-line treatment for unresectable HCC.

Conclusions:

• Donafenib represents a significant advancement in the first-line treatment of unresectable HCC.
• Its improved efficacy and tolerability address key limitations of previous therapies.
• Further review of preclinical and clinical data supports donafenib's role in HCC management.