Evaluation of the Safety, Pharmacokinetics, and Antitumor Activity of Tusamitamab Ravtansine in Patients With Nonsquamous NSCLC With High or Moderate Expression of Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5

作者：Anas Gazzah, Charles Ricordel, Antoine Italiano, Byoung Chul Cho, Emiliano Calvo, Dong-Wan Kim, Carole Hélissey, Jin-Soo Kim, Maria Vieito Villar, François Ghiringhelli, Víctor Moreno, Sophie Cousin, Luis Paz‐Ares, Nathalie Fagniez, Mustapha Chadjaa, Anne-Laure Bauchet, Christine Soufflet, Nina Masson, Fabrice Barlési · 发表于：JTO Clinical and Research Reports · 年份：2025 · DOI：10.1016/j.jtocrr.2025.100844 · 被引用次数：6 · 研究领域：Radiopharmaceutical Chemistry and Applications、HER2/EGFR in Cancer Research、Monoclonal and Polyclonal Antibodies Research

Introduction: Tusamitamab ravtansine is an antibody-drug conjugate targeting cells expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) with a maytansinoid payload, DM4. This phase 1b dose-expansion study (NCT02187848) evaluated its safety, pharmacokinetics, and preliminary antitumor activity in patients with nonsquamous NSCLC (NSq NSCLC). Methods: every 2 weeks. Results: = 0.4117) and 15 stable diseases.Treatment-emergent adverse events (AEs) occurred in 78.3% of patients (72/92), 37.0% (34/92) of patients required dose modifications, and 5.4% (5/92) discontinued treatment. The most common treatment-emergent AEs included asthenia (37.0%), keratitis (29.3%), and dyspnea (23.9%). Corneal AEs occurred in 38.0% (35/92), typically grade 1/2, reversible, and manageable by dose modifications. Conclusions: Tusamitamab ravtansine demonstrated a favorable safety profile, objective responses, and antitumor activity in patients with high CEACAM5-expressing NSq NSCLC.