ENHERTU® by AstraZeneca and Daiichi Sankyo Approved in China for Advanced HER2+ Gastric Cancer
Wednesday, August 14, 2024
Daiichi Sankyo and AstraZeneca's ENHERTU® (trastuzumab deruxtecan) has been granted conditional approval in China as a monotherapy for adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, who have already undergone at least two treatment regimens.
ENHERTU is a HER2-directed ADC that has shown significant clinical benefits in multiple HER2-expressing cancers and continues to be evaluated in global clinical trials for its efficacy and safety.
HER2 positive metastatic gastric cancer is aggressive and challenging to treat, with limited options after disease progression on initial treatment. ENHERTU offers a new and important treatment option for these patients in China.
Gastric cancer is the fifth most common cancer globally and a leading cause of cancer-related deaths. The incidence is particularly high in East Asia, with China accounting for a significant proportion of cases. HER2 positive gastric cancer, characterized by the overexpression of the HER2 protein, has limited treatment options after progression on initial therapy.
This approval is based on findings from the DESTINY-Gastric06 phase 2 trial, with full approval dependent on further confirmation from a randomized controlled trial that demonstrates clinical benefits.
Globally, around one in five gastric cancers are HER2 positive, and China accounts for over a third of global gastric cancer cases, with approximately 65% of patients diagnosed at an advanced stage. In 2022, there were around 359,000 new cases of gastric cancer and 260,000 deaths in China.
The conditional approval by China’s National Medical Products Administration (NMPA) follows the results of the DESTINY-Gastric06 phase 2 trial, where ENHERTU showed significant clinical responses in Chinese patients with HER2 positive locally advanced or metastatic gastric or GEJ adenocarcinoma who had previously been treated with two or more regimens, including a fluoropyrimidine and a platinum agent.
In the trial, ENHERTU achieved a confirmed objective response rate (ORR) of 28.8%, including one complete response and 20 partial responses, with a median progression-free survival (PFS) of 5.7 months.
This approval is also supported by data from the DESTINY-Gastric01 phase 2 trial, which involved patients from Japan and South Korea. In that trial, ENHERTU demonstrated a statistically significant improvement in ORR and median overall survival (OS) compared to chemotherapy.
This is the third approval for ENHERTU in China within two years, marking its significance in treating HER2 expressing cancers. Dave Fredrickson, Executive Vice President of the Oncology Business Unit at AstraZeneca, noted that this approval brings a much-needed targeted treatment to patients with HER2 positive metastatic gastric cancer in China.
The safety profile of ENHERTU in the DESTINY-Gastric06 trial was consistent with previous studies, with no new safety concerns identified. Grade 3 or 4 treatment-related adverse events included neutropenia, anaemia, leukopenia, thrombocytopenia, and others, with interstitial lung disease (ILD) being the most common cause of treatment discontinuation.
The DESTINY-Gastric06 trial in China evaluated ENHERTU’s safety and efficacy in patients with HER2 positive locally advanced or metastatic gastric or GEJ adenocarcinoma who had undergone two or more previous treatment regimens. The primary endpoint was ORR, with secondary endpoints including PFS, duration of response, disease control rate, overall survival, and safety.
The DESTINY-Gastric01 trial in Japan and South Korea also assessed the efficacy and safety of ENHERTU versus chemotherapy in HER2 positive gastric or GEJ adenocarcinoma patients who had progressed on at least two prior regimens.
Daiichi Sankyo and AstraZeneca are collaborating on the global development and commercialization of ENHERTU, as well as other ADCs in Daiichi Sankyo’s DXd ADC portfolio, which targets various types of cancer.
Source:daiichisankyo.com
