FDA issues second CRL for camrelizumab combo

Second complete response letter for camrelizumab plus rivoceranib as a frontline treatment for unresectable or metastatic hepatocellular carcinoma (HCC)

The U.S. Food and Drug Administration (FDA) has issued a second complete response letter (CRL) for camrelizumab plus rivoceranib as a first-line treatment for patients with unresectable or metastatic HCC. The CRL does not specify what deficiencies were identified, according to Jin Yang-gon, chairman of HLB Group.

When did the FDA issue the second complete response letter for camrelizumab and rivoceranib?

According to Korean news sources, the FDA issued the second CRL on March 20, 2025.

Who is responsible for developing camrelizumab for unresectable or metastatic HCC?

Camrelizumab is developed by Antengene Corporation, which plans to contact the FDA to address concerns raised in the CRL.

What clinical trial supports camrelizumab plus rivoceranib in unresectable HCC?

Data in this indication come from the final analysis of the phase 3 CARES-310 study (NCT03764293), presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, evaluating treatment with camrelizumab plus rivoceranib versus sorafenib in patients with unresectable or metastatic HCC.

How does camrelizumab plus rivoceranib compare with sorafenib in the CARES-310 study?

Camrelizumab plus rivoceranib shows a median overall survival of 23.8 months (95% CI, 20.6–27.2) versus 15.2 months (95% CI, 13.2–18.5) with sorafenib. Median progression-free survival was 5.6 months (95% CI, 5.5–7.4) versus 3.7 months (95% CI, 3.1–3.7), respectively (HR, 0.54; 95% CI, 0.44–0.67; P<0.0001).