AstraZeneca-Daiichi Sankyo Enhertu approved in China for patients with previously treated HER2-positive advanced or metastatic gastric cancer

The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Gastric06 Phase II trial. Full approval for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

In the DESTINY-Gastric06 trial, Enhertu demonstrated clinically meaningful efficacy in patients in China with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma previously treated with two or more prior regimens including a fluoropyrimidine agent and a platinum agent.

More than one third of the global cases of gastric cancer occur in China, with about 65% of patients presenting with advanced disease at the time of diagnosis. Approximately 359,000 new cases of gastric cancer and 260,000 deaths were reported in China in 2022. Roughly one in five gastric cancers globally are HER2-positive.

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.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, 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.”

Kiminori Nagao, Head of the Asia, South & Central America Business Unit, Daiichi Sankyo, said, “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. Our DESTINY clinical trial programme 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.”

In DESTINY-Gastric06, treatment with Enhertu (6.4mg/kg) resulted in a confirmed objective response rate (ORR) of 28.8% as assessed by independent central review. Median progression-free survival (PFS) was 5.7 months.

The safety profile of Enhertu in DESTINY-Gastric06 was consistent with previous clinical trials of Enhertu in gastric cancer with no new safety concerns identified.

The approval was also supported by results from the DESTINY-Gastric01 Phase II trial which included patients from Japan and South Korea. In the trial, patients with HER2-positive metastatic gastric cancer treated with Enhertu showed a statistically significant improvement in confirmed ORR (40.5% with Enhertu versus 11.3% with chemotherapy; p<0.0001) and median overall survival (OS) (12.5 months with Enhertu versus 8.4 months with chemotherapy; hazard ratio [HR] 0.59; 95% confidence interval [CI] 0.39-0.88; p=0.0097).

Enhertu is already approved for advanced or metastatic gastric cancer in more than 45 countries, including the US, Japan and across the EU.

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