Jia Liu, Medical oncologist at The Kinghorn Cancer Centre, shared on X:
“From presenting Phase 1 data at ESMOGI24 to Nature Medicine publication in 2025 to seeing positive Phase 3 results from G-HOPE-001 in CLDN18.2 positive 3L+ G/GEJA presented by Kohei Shitara at ESMO26!
Wonderful to have been part of the development journey of arcotatug tavatecan (IBI343), a CLDN18.2-targeting ADC!
- OS HR 0.57 (10.2 vs 6.9 mo)
- PFS HR 0.45 (7.1 vs 3.1 mo)
- Grade ≥3 treatment-related AEs: 47.4% vs 55.9%; dose reductions: 17.8% vs 35.1% compared with chemotherapy.
Congratulations to all investigators and the Innovent and Takeda teams!
Looking forward to exploring rational combinations to further improve patient outcomes!”
More thoroughly about the importance of phase 1 trial on gastroesophageal junction adenocarcinoma
- The study investigates IBI343, a CLDN18.2-targeting antibody drug conjugate (ADC), as a potential treatment for advanced gastric and gastroesophageal junction adenocarcinoma, where effective options remain limited, particularly in later treatment lines.
- In this Phase 1 trial, IBI343 achieved a confirmed objective response rate of 29% and median progression-free survival of 5.5 months among patients with high CLDN18.2 expression treated at the recommended Phase 2 dose of 6 mg/kg.
- The findings reinforce the importance of measuring CLDN18.2 expression to identify patients who may benefit from targeted therapies. No responses were observed in the small subgroup of patients whose tumors had low CLDN18.2 expression.
- IBI343 showed a manageable safety profile, with 6 mg/kg every three weeks selected as the recommended Phase 2 dose. Further studies are needed to confirm its efficacy and determine how best to sequence or combine it with other treatments.
Title: CLDN18.2-targeting antibody-drug conjugate IBI343 in advanced gastric or gastroesophageal junction adenocarcinoma: a phase 1 trial
Authors: Jia Liu, Jianwei Yang, Yuping Sun, Jifang Gong, Jinbo Yue, Yueyin Pan, Meili Sun, Rongfeng Song, Xiuying Xiao, Andrea Tazbirkova, Jian Ruan, Zhenyang Liu, Zimin Liu, Zhihua Li, Lili Sheng, Yanru Qin, Jieer Ying, Xianjun Yu, Jian Zhang, Yiping Mou, Chuangxin Lu, Ping Chen, Suyi Li, Jie Li, Xiujuan Qu, Ting Deng, Juan Du, Aiping Zhou, Enxiao Li, Xianglin Yuan, Xinjun Liang, Weiming Yu, Michelle Morris, Yang Luo, Xin Zhao, Yingmei Guo, Hui Zhou, Lin Shen
Read the full article:
You may also be interested in:
Kohei Shitara Shares Phase 2 ASPEN-06 Results in HER2-Positive Gastric Cancer
