AstraZeneca and Daiichi Sankyo'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 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.
Enhertu’s safety profile observed in DESTINY-Gastric06 aligned with previous clinical trials.
Supporting evidence for the approval also came from the DESTINY-Gastric01 Phase II trial, which involved patients from Japan and South Korea.
In this study, Enhertu significantly improved confirmed ORR and median OS compared to chemotherapy.
Enhertu is already sanctioned for use in 45 countries and regions, including Japan, the US and the European Union, for advanced or metastatic gastric cancer.
The full approval in China is contingent upon future results from a randomised controlled confirmatory trial that must demonstrate clinical benefit for this patient population.
AstraZeneca oncology business unit executive vice-president Dave Fredrickson stated: “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.”
Discovered by Daiichi Sankyo, Enhertu is being developed and commercialised jointly with AstraZeneca.
In April 2024, the US Food and Drug Administration approved Enhertu for adults with unresectable or metastatic HER2-positive [immunohistochemistry (IHC) 3+] solid tumours.
