NEW YORK – China's National Medical Products Administration (NMPA) on Tuesday approved AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) for previously treated patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction cancer.
The conditional approval was based on data from two Phase II trials, the DESTINY-Gastric06 trial and the DESTINY-Gastric01 study. Full approval of Enhertu in this indication will require a confirmatory trial that further supports its clinical benefit in this population.
The DESTINY-Gastric06 trial results from 95 Chinese patients with HER2-positive gastric cancer demonstrated an objective response rate of 28.8 percent and a median progression-free survival of 5.7 months. The DESTINY-Gastric01 study, which included patients from Japan and South Korea, demonstrated a 40.5 percent response rate on Enhertu, compared to 11.3 percent on chemotherapy. Overall survival was also improved on Enhertu in the DESTINY-Gastric01 study, with a median survival of 12.5 months on Enhertu and 8.4 months on chemo.
"China accounts for more than a third of patients with gastric cancer globally and most patients are diagnosed with advanced disease," Dave Fredrickson, executive VP of the oncology business unit at AstraZeneca, said in a statement. "This approval of Enhertu brings a much-needed, new targeted treatment option to patients with HER2-positive metastatic gastric cancer in China and underscores our commitment to bringing this innovative medicine to more patients across the globe living with HER2-expressing cancers."
Enhertu was approved in this same setting in the US in 2021 and in Europe in 2022. In China, Enhertu is also approved to treat HER2-positive metastatic breast cancer and HER2-low metastatic breast cancer.