Daiichi Sankyo/AstraZeneca’s ADC Trastuzumab Deruxtecan Receives Priority Review in China for Neoadjuvant Treatment of HER2-Positive Breast Cancer

On July 25, the CDE website showed that another new indication for the significant ADC "Trastuzumab Deruxtecan" from Daiichi Sankyo and AstraZeneca is proposed to be included in the priority review, with the indication beingFor neoadjuvant treatment in HER2-positive breast cancer patients。

Screenshot source: CDE official website

In May this year, Daiichi Sankyo and AstraZeneca jointly announced that trastuzumab deruxtecan achieved positive results in the DESTINY-Breast11 study for high-risk HER2-positive early breast cancer.

DESTINY-Breast11 is a global, multicenter, randomized, open-label Phase III clinical trial designed to evaluate trastuzumab deruxtecan.（5.4 mg/kg）Monotherapy or Trastuzumab Deruxtecan Followed by THP vs Standard Therapy（ddAC-THP）Compared to the efficacy and safety in patients with high-risk, locally advanced, or inflammatory HER2-positive early breast cancer.

The study enrolled 927 subjects at multiple trial centers in Asia, Europe, North America, and South America, who were randomly assigned in a 1:1:1 ratio to receive trastuzumab deruxtecan monotherapy, trastuzumab deruxtecan + THP, or ddAC-THP treatment. The primary endpoint of the study was pCR, with secondary endpoints including event-free survival.（EFS）, Disease-free survival, Overall survival, and Safety.

The results showed,Compared with the standard treatment regimen, trastuzumab deruxtecan combined with THP significantly improved pCR in the neoadjuvant treatment of high-risk, locally advanced HER2-positive early breast cancer patients, with statistical and clinical significance.EFS is not yet mature, but the early efficacy trend is favorable.

In terms of safety, the safety of trastuzumab deruxtecan combined with THP therapy has improved compared to ddAC-THP. The safety profiles of trastuzumab deruxtecan and THP are consistent with their known safety profiles, and no new safety concerns were identified. According to an assessment by the independent review committee, the incidence of interstitial lung disease was similar between trastuzumab deruxtecan combined with THP therapy and ddAC-THP therapy.

Trastuzumab deruxtecan is a DXd ADC targeting HER2 designed using Daiichi Sankyo's proprietary technology. In March 2019, Daiichi Sankyo and AstraZeneca entered into a $6.9 billion collaboration to jointly develop and commercialize the product worldwide.

In China, trastuzumab deruxtecan has previously been approved for four indications.(See the figure below), designing breast cancer, gastric cancer, non-small cell lung cancer. In June this year,Trastuzumab Deruxtecan forThe marketing application for second-line treatment of HER2-positive adult gastric or gastroesophageal junction adenocarcinoma has also been submitted.Included in the CDE Priority Review.

Since its first approval in 2019, Trastuzumab Deruxtecan has been approved for marketing in multiple countries and regions, including the United States, Japan, the European Union, and China. With the successive introduction of various indications, the sales of Trastuzumab Deruxtecan have also been advancing rapidly.Global sales exceeded $3.8 billion in 24 years, making it the best-selling ADC drug worldwide.。

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