AstraZeneca and Daiichi Sankyo’s Enhertu has received conditional approval in China for use in patients with HER2-positive gastro-oesophageal junction adenocarcinoma (GEJ).
The drug can be used as a monotherapy for adult patients, and those who receive it must have received at least two unsuccessful treatment regimens previously.
The National Medical Products Administration (NMPA) made this call based on data from the DESTINY-Gastric06 Phase II trial, and full approval will be granted by the regulator if the Phase III trial confirms Enhertu’s efficacy.
Enhertu is a HER2-directed antibody drug conjugate (ADC) that was originally discovered by Daiichi Sankyo.
AstraZeneca and Daiichi Sankyo are now working in tandem to develop and commercialise the immunotherapy.
In the DESTINY-Gastric06 trial, Enhertu demonstrated significant clinical efficacy in managing patients with metastatic or locally advanced gastric cancers.
The objective response rate (ORR) of participants was 28.8%, and median progression-free survival (PFS) was 5.7 months.
A study including Japanese and Korean patients also highlighted the efficacy of Enhertu, with ORR and overall survival (OS) also increasing.
Lin Shen, MD, Director of the Department of Gastrointestinal Oncology, Peking University Cancer Hospital, China, said: “HER2-positive metastatic gastric cancer can be particularly aggressive and difficult to treat. Patients often face poor outcomes following disease progression on first-line treatment and subsequent chemotherapy. With the approval of Enhertu, patients in China with HER2-positive metastatic gastric cancer will now have an important anti-HER2 treatment option that has demonstrated clinically meaningful efficacy following progression on previous therapies.”
Executive Vice President of the Oncology Business Unit at AstraZeneca, Dave Fredrickson, said: “China accounts for more than a third of patients with gastric cancer globally and most patients are diagnosed with advanced disease. 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.”
