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ArticleMedicine Guanlan
Recently, the Chinese drug clinical trial registration and information disclosure platform showed that BeiGene has launched a phase 3 study of zanidatamab (ZW25) in China for the first-line treatment of advanced HER2-positive gastroesophageal adenocarcinoma
.
Public information shows that zanidatamab is one of the two HER2 targeted therapies that BeiGene introduced from Zymeworks in 2018 for more than US$400 million.
Screenshot source: Drug clinical trial registration and information disclosure platform
Zanidatamab is a bispecific antibody that can simultaneously bind to two non-overlapping HER2 epitopes, that is, biparatopic binding
.
This unique design can form a variety of mechanisms of action, including dual blocking of HER2 signaling, enhanced binding and removal of HER2 protein on the cell surface, and powerful antibody effector functions to enhance anti-tumor activity in patients
BeiGene's launch in China this time is to evaluate zanidatamab combined with chemotherapy, with or without tislelizhu, in subjects with unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma (GEA) A randomized, multi-center, phase 3 study of the efficacy of monoclonal antibodies (anti-PD-1 monoclonal antibodies)
.
The main endpoints of the study were: Progression-free survival (PFS) and overall survival (OS) assessed by the blinded independent central review (BICR) according to RECIST1.
According to the research results reported by Zymeworks at the 2021 European Society of Medical Oncology (ESMO) annual meeting, zanidatamab combined with chemotherapy, in 28 patients with HER2-positive metastatic gastroesophageal adenocarcinoma who can evaluate the efficacy, 75% of the confirmed objective Response rate (ORR) and disease control rate (DCR) of 89%
.
Among 28 patients, only 1 patient's tumor did not shrink
Reference materials:
[1] Drug clinical trial registration and information disclosure platform.
[3] Zanidatamab Phase 2 Clinical Trial Demonstrates Promising Response Rate And Durability In First-Line HER2-Positive Gastroesophageal Adenocarcinoma (GEA) At The European Society For Medical Oncology (ESMO) Annual Congress.
