Core Viewpoint - The company Fuhong Hanlin (02696) has announced the completion of the first patient dosing in a Phase 2/3 clinical study of HLX22 combined with HLX87 for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in mainland China [1][2] Group 1 - The clinical study is an open-label, randomized, multi-center Phase 2/3 trial evaluating the efficacy of HLX22 combined with HLX87 in patients with HER2-positive recurrent or metastatic breast cancer [2] - The study consists of two phases: the first phase is a Phase 2 trial with a 2:2:1:1 randomization ratio for treatment groups, including HLX22 combined with HLX87, and various combinations of other therapies [2] - The primary endpoint of the first phase is the objective response rate (ORR) and progression-free survival (PFS) assessed by an independent imaging review committee (BICR) [2] Group 2 - The second phase is a Phase 3 trial with a 1:1 randomization ratio comparing HLX22 combined with HLX87 to other treatment combinations [2] - The primary endpoint of the second phase is PFS evaluated by BICR [2] - The main objective of the study is to assess the clinical efficacy of HLX22 combined with HLX87, with secondary objectives including safety, tolerability, pharmacokinetics (PK), immunogenicity, and exploration of potential predictive or resistance biomarkers [2]
复宏汉霖：HLX22联合注射用HLX87一线治疗HER2阳性复发或转移性乳腺癌(BC)患者的2/3期临床研究于中国境内完成首例患者给药