DOI 10.3760/cma.j.cn112152-20260629-00300
[Expert Consensus on Clinical Application of Izalontamab Brengitecan (2026 Edition)].
Аннотация
Izalontamab brengitecan (iza-bren) is the first approved bispecific antibody-drug conjugate (BsADC), comprising an EGFR/HER3-targeting bispecific antibody conjugated to a novel topoisomerase I inhibitor (Ed-04) via a stable tetrapeptide cleavable linker. Iza-bren demonstrated positive results by meeting the primary endpoints in registrational Phase III trials conducted in nasopharyngeal carcinoma, esophageal squamous cell carcinoma, and triple-negative breast cancer. In June 2026, iza-bren was approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with recurrent/metastatic nasopharyngeal carcinoma who have failed at least two prior lines of systemic chemotherapy and PD-1/PD-L1 inhibitor therapy; in July 2026, iza-bren was approved for the treatment of adult patients with recurrent or metastatic esophageal squamous cell carcinoma who have experienced disease progression after prior therapy with a PD-1/PD-L1 inhibitor in combination with platinum-containing chemotherapy. As a first-in-class antineoplastic agent, iza-bren is poised for widespread clinical application following its approval. To optimize patient outcomes, this consensus, developed by 182 clinical experts across multiple tumor types through iterative discussions, provides guidance on the safe and effective use of iza-bren and the clinical management of its associated adverse events.
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