and ‘s antibody drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) has received conditional approval from the China National Medical Products Administration (NMPA) for gastric cancer. The approval allows Enhertu to be used as a single agent for adults with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have undergone a minimum of two previous treatment regimens. The gold standard of business intelligence.
The NMPA’s decision was influenced by the positive outcomes of the DESTINY-Gastric06 Phase II trial – an open-label, single-arm study that evaluated Enhertu’s safety and efficacy in Chinese patients with previously treated HER2-positive gastric or GEJ adenocarcinoma. DESTINY-Gastric06’s primary endpoint was the confirmed objective response rate (ORR) as determined by an independent central review. The trial also looked at secondary endpoints: investigator-assessed ORR, progression-free survival (PFS), duration of response, disease control rate, overall survival (OS) and safety.
In the trial, the ADC achieved a confirmed ORR of 28.8% and a median PFS of 5.7 months.
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