Enhertu, developed by AstraZeneca and Daiichi Sankyo, has gained conditional approval in China for use in patients with advanced or metastatic HER2-positive gastric cancer who have previously undergone two or more treatment regimens.
The approval is based on the positive results from the DESTINY-Gastric06 Phase II clinical trial, which demonstrated the drug's efficacy in this patient group.
This marks the third approval for Enhertu in China within the past two years.
AstraZeneca and Daiichi Sankyo have announced that their drug Enhertu (trastuzumab deruxtecan) has been conditionally approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have already received at least two prior treatments. This decision was influenced by the promising outcomes of the DESTINY-Gastric06 Phase II trial.
However, a full approval will depend on the results of a confirmatory clinical trial demonstrating further clinical benefits for this patient group.
Enhertu is a specially engineered HER2-directed antibody-drug conjugate (ADC), originally discovered by Daiichi Sankyo. It is now being jointly developed and marketed by AstraZeneca and Daiichi Sankyo.
In the DESTINY-Gastric06 trial, Enhertu showed significant efficacy in treating Chinese patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who had undergone two or more prior treatment regimens, including a fluoropyrimidine and a platinum-based therapy.
In China, gastric cancer is particularly prevalent, with over a third of the global cases occurring there. Approximately 65% of Chinese patients are diagnosed at an advanced stage of the disease, leading to high mortality rates. In 2022 alone, there were about 359,000 new cases and 260,000 deaths due to gastric cancer in the country. HER2-positive cases account for roughly one-fifth of gastric cancer diagnoses worldwide.
The DESTINY-Gastric06 trial showed that treatment with Enhertu (6.4 mg/kg) resulted in an objective response rate (ORR) of 28.8%, as confirmed by an independent central review. The median progression-free survival (PFS) was reported at 5.7 months. Importantly, the safety profile of Enhertu in this trial was consistent with previous studies, and no new safety issues were observed.
The approval in China is also supported by data from the DESTINY-Gastric01 Phase II trial, which involved patients from Japan and South Korea. In this trial, Enhertu demonstrated a significant improvement in ORR and overall survival (OS) compared to chemotherapy. Specifically, the ORR with Enhertu was 40.5% compared to 11.3% with chemotherapy, and the median OS was 12.5 months with Enhertu versus 8.4 months with chemotherapy.
Enhertu has already been approved for the treatment of advanced or metastatic gastric cancer in over 45 countries, including the United States, Japan, and several European Union nations.
DESTINY-Gastric06 Trial Overview
DESTINY-Gastric06 is an open-label, single-arm Phase II trial conducted in China. It evaluated the safety and efficacy of Enhertu (6.4 mg/kg) in patients with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma who had previously been treated with at least two regimens, including a fluoropyrimidine and a platinum-based therapy. The trial's primary endpoint was the confirmed ORR, assessed by an independent central review, while secondary endpoints included investigator-assessed ORR, PFS, duration of response (DoR), disease control rate (DCR), overall survival (OS), and safety. The trial enrolled 95 patients across multiple sites in China.
DESTINY-Gastric01 Trial Overview
DESTINY-Gastric01 is a Phase II, open-label, multi-center, randomized controlled trial that tested the safety and efficacy of Enhertu (6.4 mg/kg) against the physician's choice of chemotherapy in patients from Japan and South Korea with HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma. These patients had previously undergone at least two treatment regimens, including trastuzumab in combination with a fluoropyrimidine and platinum-based chemotherapy. The trial involved 188 participants who were randomized in a 2:1 ratio to receive either Enhertu or chemotherapy (paclitaxel or irinotecan). The primary endpoint was ORR, as evaluated by independent central review, while key secondary endpoints included OS, PFS, DoR, DCR, and safety.
About Enhertu
Enhertu is a HER2-directed antibody-drug conjugate (ADC), designed using Daiichi Sankyo’s proprietary DXd ADC technology. It is a leading drug in Daiichi Sankyo’s oncology portfolio and a key component of AstraZeneca’s ADC platform. Enhertu comprises a HER2 monoclonal antibody linked to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via cleavable tetrapeptide-based linkers.
Enhertu is currently approved in over 65 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received an anti-HER2-based regimen. It is also approved for HER2-low breast cancer and HER2-mutant non-small cell lung cancer (NSCLC) in multiple countries, with continued approvals often dependent on the verification of clinical benefits in ongoing trials.
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