By Fineline Cube 
China-based CStone Pharmaceuticals (HKG: 2616) announced the latest progress in its global multicenter Phase III study (CS1003-305) evaluating nofazinlimab (CS1003), a PD-1 monoclonal antibody, in combination with lenvatinib as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC).
Study Design and Endpoints
The CS1003-305 study, conducted across 74 research centers worldwide, is a double-blind, randomized controlled trial. The primary endpoint is overall survival (OS), with key secondary endpoints including blinded independent central review-assessed progression-free survival (PFS) and objective response rate (ORR).
Clinical Outcomes
The final analysis showed a clear trend of clinical benefit in OS with the nofazinlimab/lenvatinib combination, although statistical significance was not achieved. This indicates a potential real-world benefit for patients. Additionally, clinically meaningful improvements were observed in PFS and ORR, with data comparable to existing standard therapies.
Safety Profile
The combination therapy exhibited a favorable safety profile, with no new safety signals identified.
Drug Background
Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody that binds to PD-1 with high affinity, blocking its interaction with PD-L1/PD-L2. The U.S. FDA granted the drug orphan drug designation (ODD) for HCC in July 2020.-Fineline Info & Tech