Core Insights - Company announced the latest progress of the CS1003-305 study, a Phase III clinical trial evaluating the efficacy and safety of PD-1 monoclonal antibody nofazinlimab in combination with lenvatinib for patients with unresectable or metastatic hepatocellular carcinoma (HCC) [1] - The study involved 74 research centers globally and aimed to compare the combination therapy against placebo plus lenvatinib, with overall survival (OS) as the primary endpoint [1] - Final analysis indicated a clear clinical benefit trend for the combination therapy, although it did not reach statistical significance, showing tangible patient benefits [1] - The combination therapy also demonstrated clinically meaningful improvements in progression-free survival (PFS) and objective response rate (ORR), comparable to current standard treatments [1] - Nofazinlimab exhibited good safety profile consistent with previous studies and existing PD-(L)1 antibodies, with no new safety signals observed [1] - The company plans to communicate with regulatory authorities to seek a registration pathway for the combination therapy [1] Product Information - Nofazinlimab is a humanized recombinant IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1), developed for tumor immunotherapy [2] - It has high affinity for PD-1 in humans, crab-eating macaques, and mice, blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2 [2] - Nofazinlimab received Orphan Drug Designation (ODD) from the FDA in July 2020 for the treatment of hepatocellular carcinoma [2]
基石药业-B(02616.HK)宣布有关CS1003-305研究最新进展