AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been conditionally approved in China for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have undergone two or more prior treatments. The approval by the National Medical Products Administration (NMPA) is based on positive results from the DESTINY-Gastric06 Phase II trial, with full approval contingent on further confirmation of clinical benefits in a randomized controlled trial.
Enhertu, a HER2-directed antibody-drug conjugate (ADC) developed by Daiichi Sankyo and co-commercialized with AstraZeneca, demonstrated significant efficacy in patients in China with advanced HER2-positive gastric or GEJ adenocarcinoma who had previously received at least two treatment regimens.
Gastric cancer is prevalent in China, accounting for over a third of global cases, with many patients presenting with advanced disease. In 2022, approximately 359,000 new cases and 260,000 deaths were reported in the country. HER2-positive gastric cancer, a particularly aggressive form, comprises about 20% of global gastric cancer cases.
Dr. Lin Shen, Director of Gastrointestinal Oncology at Peking University Cancer Hospital, highlighted that HER2-positive metastatic gastric cancer often results in poor outcomes after initial treatments, making Enhertu an important new option for patients in China.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, emphasized that Enhertu offers a crucial targeted treatment for Chinese patients, reflecting AstraZeneca’s commitment to addressing HER2-expressing cancers worldwide.
Kiminori Nagao, Head of Daiichi Sankyo’s Asia, South & Central America Business Unit, noted that this marks the third approval for Enhertu in China within two years, following its approval for HER2-positive and HER2-low metastatic breast cancer. The DESTINY clinical trials continue to reinforce Enhertu’s role as a transformative treatment for HER2-expressing cancers.
In the DESTINY-Gastric06 trial, Enhertu (6.4mg/kg) achieved a confirmed objective response rate (ORR) of 28.8% and a median progression-free survival (PFS) of 5.7 months. The safety profile was consistent with previous trials, with no new safety concerns.
The approval was further supported by results from the DESTINY-Gastric01 Phase II trial, which included patients from Japan and South Korea. Enhertu showed a significant improvement in ORR (40.5% vs. 11.3% with chemotherapy) and overall survival (12.5 vs. 8.4 months).
Enhertu is approved in over 45 countries, including the US, Japan, and across the EU, for advanced or metastatic gastric cancer.
Notes on HER2-Positive Gastric Cancer
Gastric cancer is the fifth most common cancer globally, with a poor prognosis for advanced or metastatic cases. In 2022, around one million new cases were diagnosed worldwide, with over 660,000 deaths. HER2-positive gastric cancer, driven by the HER2 protein, represents about 20% of these cases. In China, the incidence is particularly high, with over 65% of patients diagnosed at an advanced stage.
DESTINY-Gastric Trials
DESTINY-Gastric06 is a Phase II trial in China evaluating Enhertu in patients with HER2-positive advanced or metastatic gastric or GEJ adenocarcinoma after two or more prior treatments. DESTINY-Gastric01, conducted in Japan and South Korea, tested Enhertu against chemotherapy in a similar patient group.
Enhertu Overview
Enhertu, a HER2-directed ADC developed by Daiichi Sankyo, uses proprietary DXd technology and is a key part of AstraZeneca’s ADC platform. It is approved globally for various HER2-positive cancers, including breast, lung, and gastric cancers, based on results from several DESTINY trials.
AstraZeneca and Daiichi Sankyo Collaboration
The two companies are collaborating globally to develop and commercialize Enhertu, with Daiichi Sankyo responsible for manufacturing and supply.
AstraZeneca in Oncology
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