Telisotuzumab adizutecan (ABBV-400; Temab-A) monotherapy vs trifluridine/tipiracil plus bevacizumab in patients with refractory metastatic colorectal cancer with increased c-Met protein expression: An open-label, randomized, phase 3 trial.

作者：John H. Strickler, Akihito Kawazoe, Jian Li, Lin Shen, Hua Fang, Martha Raluca Neagu Aristide, Athanasios Vasilopoulos, Yunxia Sui, Rabih Saab, Carla Biesdorf de Almeida, Kanwal Pratap Singh Raghav · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.tps3635 · 被引用次数：3 · 研究领域：Colorectal Cancer Treatments and Studies、Gastric Cancer Management and Outcomes、Cancer Research and Treatments

TPS3635 Background: c-Met protein expression is increased in several solid tumors, including colorectal cancer (CRC). Temab-A is a c-Met–directed antibody-drug conjugate consisting of the antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. Preliminary data from the ongoing first-in-human study of Temab-A (NCT05029882) indicate a tolerable safety profile and promising antitumor activity in patients with third-line or later metastatic (m)CRC (Sharma et al. JCO 2023;41:3015). Herein, we describe a phase 3 study comparing Temab-A monotherapy with the standard of care (trifluridine/tipiracil plus bevacizumab) in patients with refractory mCRC with c-Met expression of 3+ in ≥10% of tumor cells by immunohistochemistry (IHC). Methods: This is an open-label, randomized, controlled, global phase 3 study(NCT06614192). Patient eligibility includes age ≥18 years, confirmed c-Met expression of 3+ in ≥10% of tumor cells, metastatic adenocarcinoma of the colon/rectum, measurable disease per RECIST v1.1, ECOG performance status 0–1, prior treatment with a fluoropyrimidine (eg, 5-FU or capecitabine), oxaliplatin, irinotecan, and an anti-VEGF antibody (unless locally not approved) or an anti-EGFR antibody if indicated, and appropriate targeted therapy or immunotherapy if targetable mutations present (eg, BRAF V600E or HER2 ) or MSI-H/dMMR. Prior treatment with regorafenib and/or fruquintinib is permitted, but no prior treatment with trifluridine/tipiracil Study-speci...