AstraZeneca Monotherapy for Gastric Cancer Gains Third Approval in China

Enhertu (trastuzumab deruxtecan), a human epidermal growth factor receptor 2 (HER2)-directed antibody-drug conjugate jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, received conditional approval from the National Medical Products Administration of China for monotherapy treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GER) adenocarcinomas, provided those patients have received two or more prior treatment regimens, AstraZeneca announced in a press release on Aug. 13, 2024 (1).

The approval decision was based on positive results of a Phase II trial (DESTINY-Gastric06), indicating that Enhertu “demonstrated clinically meaningful efficacy” in patients in China, which is home to more than one-third of all global cases of gastric cancer—359,000 new cases and 260,000 deaths having been reported in 2022 (1,2). About 65% of patients in China present with advanced disease by the time of diagnosis, and approximately one in five gastric cancers around the world are HER2-positive (1).

“HER2-positive metastatic gastric cancer can be particularly aggressive and difficult to treat,” said Lin Shen, MD, director of the department of gastrointestinal oncology at Peking University Cancer Hospital in China, in the AstraZeneca press release. “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.”

In the Phase II trial, a 6.4 mg/kg dose of Enhertu yielded a confirmed objective response rate of 28.8%, as assessed by independent review, and the median length of progression-free survival was 5.7 months (1).

“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,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in the release.

AstraZeneca and Daiichi Sankyo agreed to develop Enhertu in March 2019, and since then, the therapy has been approved in some form for various patient groups in more than 65 countries (1,3).

“This milestone marks the third approval in China for Enhertu in less than two years, following approvals for HER2-positive metastatic breast cancer and HER2-low metastatic breast cancer,” Kiminori Nagao, head of the Asia, South & Central America Business Unit of Daiichi Sankyo, said in the release. “Our DESTINY clinical trial program continues to reinforce Enhertu as a practice-changing treatment option for patients with HER2-expressing cancers, and this latest approval in China further illustrates the global impact of this innovative antibody drug conjugate.”

References

1. AstraZeneca. Enhertu Approved in China for Patients with Previously Treated HER2-Positive Advanced or Metastatic Gastric Cancer. Press Release. Aug. 13, 2024.
2. National Library of Medicine. Study of T-DXd Monotherapy in Patients with HER2-expressing Locally Advanced or Metastatic Gastric or GEJ Adenocarcinoma Who Have Received 2 or More Prior Regimens (DG-06). ClinicalTrials.gov, May 7, 2024 (accessed Aug. 13, 2024).
3. AstraZeneca. AstraZeneca and Daiichi Sankyo Enter Collaboration for Novel HER2-Targeting Antibody-Drug Conjugate. Press Release. March 28, 2019.