Daiichi Sankyo and AstraZeneca's TROP2-targeting antibody-drug conjugate (ADC), Dazhuoyou (generic name: dedaburumab for injection), has been approved by the China National Medical Products Administration for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have previously received endocrine therapy and at least one line of chemotherapy in the advanced stage of the disease.
Dazhuoyou is an Xd antibody-drug conjugate (ADC) targeting TROP2 developed using unique technology. It was developed by Daiichi Sankyo and co-developed with AstraZeneca. This is also the second DXd ADC designed using Daiichi Sankyo's DXd ADC technology and approved in China.
Breast cancer ranks second among malignant tumors in women in my country. In 2022, there were approximately 357,000 new cases of breast cancer in China, with approximately 75,000 deaths, posing a serious threat to women's health. Approximately 70% of confirmed cases were HR-positive, HER2-negative breast cancers, as previously thought.
This approval is based on positive results from the global Phase III TROPION-Breast01 study. In this study, derdabrocitinib significantly reduced the risk of disease progression or death by 37% compared to investigator-selected chemotherapy in patients with HR-positive, HER2-negative metastatic breast cancer, as assessed by blinded independent central review (BICR). In the study population, derdabrocitinib extended median progression-free survival (mPFS) to 6.9 months, compared to 4.9 months for patients receiving chemotherapy.
An exploratory analysis of 83 patients enrolled in the TROPION-Breast01 trial in China showed that patients treated with derdabrocitinib had a median progression-free survival (PFS) of 8.1 months, compared to 4.2 months for those receiving chemotherapy (hazard ratio, 0.54; 95% confidence interval, 0.30-0.96). A confirmed objective response rate (ORR) of 38.6% was observed in the derdabrocitinib group, compared to 17.9% in the chemotherapy group.
Professor Xu Binghe, Director of the Center for Drug Clinical Trials (GCP) at the Cancer Hospital, Chinese Academy of Medical Sciences, National Cancer Center, and lead investigator for TROPION-Breast01 in China, said: "Although we have made some progress in the treatment of HR-positive, HER2-negative metastatic breast cancer, patients still face limited treatment options once their disease progresses after endocrine therapy and chemotherapy. The approval of dedabrafenib, a novel, TROP2-targeting antibody-drug conjugate (ADC), represents another important step in expanding treatment diversity and providing more treatment options for breast cancer patients."
"The approval of Dazhuo provides a new treatment opportunity for patients with HR-positive, HER2-negative metastatic breast cancer, allowing them to receive a novel ADC targeting TROP2," said Tomohiro Hayashi, President of Daiichi Sankyo (China). "This is Daiichi Sankyo's second ADC approved for breast cancer treatment in China, following Ulheride. This further enriches our product portfolio and precisely addresses the treatment needs of patients with different breast cancer subtypes."
Lu Wenbin, General Manager of Daiichi Sankyo (China) Development Headquarters, said, "Dazhuoyou is our second antibody-drug conjugate developed based on our unique DXdADC technology platform. Clinical research data show that Dazhuoyou can significantly prolong the progression-free survival (PFS) of patients with HR-positive, HER2-negative metastatic breast cancer and improve patients' treatment outcomes. This achievement not only demonstrates the leading advantage of Daiichi Sankyo's DXdADC technology platform in the field of precision tumor treatment, but also further consolidates our position in innovative drugs .""We are committed to strengthening our global competitiveness in drug R&D. In the future, we will continue to cultivate this innovative platform, upholding a patient-centric philosophy, and provide better treatment options for cancer patients around the world."

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