Core Viewpoint - The announcement from Fuhong Hanlin (02696) highlights the completion of the first patient dosing in Japan for a Phase III clinical trial comparing HLX22 combined with chemotherapy against trastuzumab and chemotherapy, with or without pembrolizumab, for treating HER2-positive locally advanced or metastatic gastric and gastroesophageal junction cancer [1][2] Group 1 - The study is a double-blind, international, multicenter randomized controlled Phase III trial aimed at comparing the efficacy and safety of HLX22 combined with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab in first-line treatment of HER2-positive locally advanced or metastatic gastric cancer [2] - Eligible participants will be randomly assigned in a 1:1 ratio to either the experimental group (receiving HLX22 at 15 mg/kg combined with trastuzumab and chemotherapy) or the control group (receiving placebo combined with trastuzumab and chemotherapy, with or without pembrolizumab) [2] - The primary endpoints of the study include progression-free survival (PFS) and overall survival (OS) assessed by an independent radiology review committee (IRRC) based on RECIST v1.1 [2] Group 2 - Secondary endpoints include investigator-assessed PFS, objective response rate (ORR) evaluated by either the IRRC or investigators, PFS2, duration of response (DOR), quality of life, safety, immunogenicity, and pharmacokinetic characteristics [2]
复宏汉霖(02696)：HLX22联合XELOX对比XELOX联合或不联合帕博利珠单抗一线治疗HER2阳性局部晚期或转移性胃食管交界部和胃癌的国际多中心3期临床研究完成日本首例患者给药