donaFenib plus anti-PD-1 antibody

The combination therapy of donafenib plus anti-PD-1 antibody is a dual-targeting therapeutic approach combining a multikinase inhibitor (donaFenib) with immune checkpoint inhibition (anti-PD-1 antibody). DonaFenib is a new generation small molecule multikinase inhibitor that has shown superior efficacy compared to sorafenib in first-line treatment of advanced HCC (based on the ZGDH3 study). Anti-PD-1 antibodies restore T-cell function by blocking the PD-1/PD-L1 immune checkpoint. This combination leverages complementary mechanisms: donaFenib targets multiple kinases involved in tumor angiogenesis and proliferation, while the anti-PD-1 antibody enhances anti-tumor immune responses. It has been investigated in various clinical settings, particularly for hepatocellular carcinoma (HCC), including first-line treatment for unresectable HCC, adjuvant therapy after surgical resection for high-risk HCC, and triple combination therapy with transarterial chemoembolization (TACE) for advanced HCC. It is also being evaluated as neoadjuvant therapy for locally advanced thyroid cancer. Clinical outcomes reported include improved progression-free survival (PFS) and overall survival (OS) compared to single-agent treatments, higher objective response rates (ORR) and disease control rates (DCR), and durable antitumor responses with a manageable safety profile.

Other names

donafenib plus anti-PD-1 antibodydonafenib combined with PD-1 inhibitordonafenib + immune checkpoint inhibitor