Daiichi Sankyo/AstraZeneca’s Trastuzumab Deruxtecan Granted Third Indication in China for HER2-Positive Gastric Cancer
Daiichi-Sankyo
Pharmaceutical R&D Developer
On August 13, the official website of NMPA showed that Daiichi Sankyo Company Limited submitted Trastuzumab Deruxtecan (Application No.: JXSS2300089) New indication marketing application has been approved,Monotherapy is indicated for third-line treatment of HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma.。Trastuzumab Deruxtecan (DS-8201，Enhertu) is a HER2-targeted antibody-drug conjugate (ADC), jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
Screenshot source:NMPA Official Website
Trastuzumab DeruxtecanApproved for the first time in China in February 2023, as a single agent for the treatment ofUnresectable or MetastaticHER2-Positive Adult Breast Cancer PatientsThese patients had previously received one or more anti-HER2 drug treatments. In July 2023, the drug was again approved in China, as a single agent for the treatment ofUnresectable or MetastaticHER2 Low-Expressing Adult Breast Cancer PatientsThese patients had previously received at least one systemic treatment during the metastatic disease stage, or relapsed within 6 months during or after adjuvant chemotherapy.
This is the third indication for trastuzumab deruxtecan approved in China, as a monotherapy for the treatment of locally advanced or metastatic cancer that has previously received two or more prior treatment regimens.HER2-positive adult patients with gastric or gastroesophageal junction adenocarcinoma. Previously, the application had been included in the priority review by the CDE.
According to the Insight database, Daiichi Sankyo and AstraZeneca have completed a single-arm, non-randomized Phase 2 clinical study in China (DESTINY Gastric06), this trial aims to evaluate the efficacy of trastuzumab deruxtecan monotherapy in HER2-positive locally advanced or metastatic gastric adenocarcinoma or gastroesophageal junction (GEJ) The safety and efficacy in patients with adenocarcinoma.
At the 2023 ESMO Congress, researchers presented the results of this Phase II clinical trial. The data showed that patients treated with trastuzumab deruxtecan (as evaluated by the Independent Review Committee,IRC) AssessedObjective Response Rate (ORR) is 28.8%（Primary Endpoint of the Trial). In terms of secondary endpoints of the trial, the patientsMedian Duration of Response (mDOR) was 7.9 months，Median Progression-Free Survival (mPFS) was 5.7 months, median overall survival (mOS ) was 10.2 months，The ORR assessed by the investigator was 35.6%.。
The study suggests that preliminary analysis shows,Trastuzumab DeruxtecanFor HER2-positive advanced cancer in ChinaGastric adenocarcinoma or gastroesophageal junctionAdenocarcinomaPatientClinically meaningful, durable objective responses and manageable safety profile, consistent with the DESTINY-Gastric01 study (Clinical trials conducted in Japan/Korea for such patients) The results are consistent.
DESTINY Gastric06 Overview of Research
Screenshot from:Insight Database Official Website
Trastuzumab deruxtecan is a key ADC drug from Daiichi Sankyo and AstraZeneca. Since its first approval in 2019, the drug has been approved for marketing in multiple countries and regions including the United States, Japan, the European Union, and China. Its indications cover HER2-positive breast cancer, HER2-positive gastric cancer, HER2-low breast cancer, HER2-mutant non-small cell lung cancer, and HER2-positive solid tumors.
As the approved indications and regions continue to expand, the sales of trastuzumab deruxtecan are also increasing year by year. In 2023,Trastuzumab deruxtecan global sales exceed $2.7 billion, with a year-on-year growth rate of 70.82%. According to Daiichi Sankyo's recent release of the first quarter of 2024 (April-June) Financial Report,Trastuzumab deruxtecan global sales reached $831 million from April to June this year（12.96 billion yen），Increased by 58.6% year-on-year 。Daiichi Sankyo expects that the product's sales will exceed the US$3 billion mark in the fiscal year 2024, reaching US$3.261 billion.。
It is worth mentioning that, from April to June this year,Trastuzumab Deruxtecan Revenue in China Reached 1.175 Billion RMB (24 Billion JPY), a Year-on-Year Increase of 159.5%With the approval of this new indication, the revenue of Trastuzumab Deruxtecan in China is expected to continue to grow significantly.
Trastuzumab Deruxtecan Annual Sales
Screenshot from:Insight Database Official Website
