Core Viewpoint - The company, Junshi Biosciences (复宏汉霖), has announced the completion of the first patient dosing in a Phase 2/3 clinical study of HLX22 in combination with HLX87 for the treatment of HER2-positive recurrent or metastatic breast cancer in mainland China [1][2]. Group 1: Clinical Study Overview - The study is an open-label, randomized, multi-center Phase 2/3 clinical trial evaluating the efficacy of HLX22 combined with HLX87 in treating HER2-positive recurrent or metastatic breast cancer patients [2]. - The first phase involves a randomized, parallel-controlled design with a 2:2:1:1 allocation ratio for participants receiving HLX22 combined with HLX87, or other combinations including pertuzumab and trastuzumab [2]. - The primary endpoints for the first phase include objective response rate (ORR) and progression-free survival (PFS) assessed by an independent imaging review committee (BICR) [2]. Group 2: Study Objectives and Design - The second phase of the study is also an open-label, randomized, multi-center trial, with participants allocated in a 1:1 ratio to receive either HLX22 combined with HLX87 or pertuzumab combined with trastuzumab and docetaxel [2]. - The main objective of the study is to evaluate the clinical efficacy of HLX22 combined with HLX87 in treating HER2-positive recurrent or metastatic breast cancer, while secondary objectives include assessing safety, tolerability, pharmacokinetics (PK), immunogenicity, and exploring potential predictive or resistance biomarkers [2].
复宏汉霖(02696)：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