Trastuzumab Deruxtecan Launches in Boao Lecheng to Benefit HER2-Positive Breast and Gastric Cancer Patients in China
Mar 03, 2022 12:46
CST Updated
12:46
Daiichi-Sankyo
Pharmaceutical R&D Developer
AstraZeneca
Biopharmaceutical Manufacturer
On March 3, 2022, trastuzumab deruxtecan (Enhertu®, T-DXd, also known as DS-8201), a HER2-targeted antibody-drug conjugate jointly developed and promoted by Daiichi Sankyo (China) and AstraZeneca, was introduced in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China. It is used to treat HER2-positive unresectable or recurrent breast cancer after previous chemotherapy (only for patients who are resistant to or intolerant of standard treatment) and HER2-positive advanced unresectable or recurrent gastric cancer with disease progression after previous chemotherapy. Recently, the first Chinese patient with HER2-positive breast cancer has successfully started treatment with T-DXd, marking the drug's first clinical application in China and bringing new hope to Chinese cancer patients.
Breast cancer is the most common malignant tumor among women in China, with approximately 420,000 new cases in 2020. Among these, HER2-positive breast cancer accounts for about 20% of all molecular subtypes of breast cancer. It is characterized by rapid progression, a high likelihood of recurrence and metastasis, poor patient prognosis, and higher mortality risk. For patients with HER2-positive metastatic breast cancer, disease control remains less than optimistic after initial treatment with trastuzumab and taxanes. To address the urgent unmet treatment needs of patients, Daiichi Sankyo has partnered with AstraZeneca and Hainan Lecheng Pilot Zone to sign the "Hainan Innovative Strategic Cooperation Memorandum in the Field of Antibody-Drug Conjugates," accelerating the introduction of innovative oncology therapies.
T-DXd is a novel anti-HER2 targeted antibody-drug conjugate (ADC) based on Daiichi Sankyo's proprietary DXd ADC technology. It consists of a humanized anti-HER2 lgG1 antibody, a cleavable tetrapeptide linker, and a topoisomerase I inhibitor (DXd, a camptothecin derivative), offering the dual advantages of precise targeting and high efficacy with low toxicity. T-DXd has previously been approved for use in multiple countries worldwide and has received four Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA).
According to the data from the large-scale Phase III clinical trial DESTINY-Breast03, compared with the previous standard treatment T-DM1, the risk of disease progression or death was reduced by 72% after patients were treated with T-DXd. The median PFS evaluated by investigators reached 25.1 months, the objective response rate (ORR) was 79.7%, and the disease control rate exceeded 95%, bringing significant clinical benefits and survival advantages to patients. With its groundbreaking efficacy, T-DXd has redefined the treatment landscape for HER2-positive metastatic breast cancer and has been recommended by international guidelines such as NCCN and ESMO as the standard regimen for second-line treatment of HER2-positive advanced breast cancer.
With the continuous upgrading of medical insurance policies, T-DXd has been included in the Boao Lecheng Global Special Drug Insurance in Hainan, Beijing Inclusive Health Insurance, and Shanxi Jinhui Insurance, greatly enhancing the affordability and accessibility of the drug. It is expected to benefit more patients in China in the future.
Lyu Xiaolei, Standing Deputy Director and Party Committee Member of the Boao Lecheng International Medical Tourism Pilot Zone Administration in Hainan, stated: "We are very pleased to see the successful introduction of T-DXd, a globally leading innovative oncology drug. As an important gateway for introducing advanced international medical technologies into China, Lecheng Pilot Zone is accelerating the aggregation of high-quality resources. The optimized version 3.0 of the special medical device policy in Lecheng will benefit more patients in China, while the Lecheng Special Drug Insurance also ensures the affordability of these medications."
Professor Ma Fei from the National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences, stated: "The results of the DESTINY-Breast03 study indicate that T-DXd can effectively reduce the risk of disease progression or death and significantly improve the objective response rate, establishing a new standard for second-line treatment in HER2-positive breast cancer patients. Thanks to the policy advantages of early adoption and global special drug insurance, we have synchronized with the latest international treatment options, bringing new hope to HER2-targeted therapy in China. We look forward to continuing to benefit more patients in the future."
[References]
1. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
2. Shui R, Liang X, Li X, et al. Hormone Receptor and Human Epidermal Growth Factor Receptor 2 Detection in Invasive Breast Carcinoma: A Retrospective Study of 12,467 Patients From 19 Chinese Representative Clinical Centers. Clin Breast Cancer. 2020;20(1):e65-e74.
3. Barok M, et al. Trastuzumab emtansine: mechanism of action and drug resistance. Breast Cancer Res. 2014;16(2):209.
4. Mounsey, L et al. Changing Natural History of HER2-Positive Breast Cancer Metastatic to the Brain in the Era of New Targeted Therapies. Clin Breast Cancer. 2018; 18(1):29-37.
5. Martinez-S Sáez O, et al. Current and Future Management of HER2-Positive Metastatic Breast Cancer. JCO Oncol Pract. 2021.10.1200/OP.21.00172.
6. DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03], ClinicalTrials.gov.
Breast cancer is the most common malignant tumor among women in China, with approximately 420,000 new cases in 2020. Among these, HER2-positive breast cancer accounts for about 20% of all molecular subtypes of breast cancer. It is characterized by rapid progression, a high likelihood of recurrence and metastasis, poor patient prognosis, and higher mortality risk. For patients with HER2-positive metastatic breast cancer, disease control remains less than optimistic after initial treatment with trastuzumab and taxanes. To address the urgent unmet treatment needs of patients, Daiichi Sankyo has partnered with AstraZeneca and Hainan Lecheng Pilot Zone to sign the "Hainan Innovative Strategic Cooperation Memorandum in the Field of Antibody-Drug Conjugates," accelerating the introduction of innovative oncology therapies.
T-DXd is a novel anti-HER2 targeted antibody-drug conjugate (ADC) based on Daiichi Sankyo's proprietary DXd ADC technology. It consists of a humanized anti-HER2 lgG1 antibody, a cleavable tetrapeptide linker, and a topoisomerase I inhibitor (DXd, a camptothecin derivative), offering the dual advantages of precise targeting and high efficacy with low toxicity. T-DXd has previously been approved for use in multiple countries worldwide and has received four Breakthrough Therapy Designations from the U.S. Food and Drug Administration (FDA).
According to the data from the large-scale Phase III clinical trial DESTINY-Breast03, compared with the previous standard treatment T-DM1, the risk of disease progression or death was reduced by 72% after patients were treated with T-DXd. The median PFS evaluated by investigators reached 25.1 months, the objective response rate (ORR) was 79.7%, and the disease control rate exceeded 95%, bringing significant clinical benefits and survival advantages to patients. With its groundbreaking efficacy, T-DXd has redefined the treatment landscape for HER2-positive metastatic breast cancer and has been recommended by international guidelines such as NCCN and ESMO as the standard regimen for second-line treatment of HER2-positive advanced breast cancer.
With the continuous upgrading of medical insurance policies, T-DXd has been included in the Boao Lecheng Global Special Drug Insurance in Hainan, Beijing Inclusive Health Insurance, and Shanxi Jinhui Insurance, greatly enhancing the affordability and accessibility of the drug. It is expected to benefit more patients in China in the future.
Lyu Xiaolei, Standing Deputy Director and Party Committee Member of the Boao Lecheng International Medical Tourism Pilot Zone Administration in Hainan, stated: "We are very pleased to see the successful introduction of T-DXd, a globally leading innovative oncology drug. As an important gateway for introducing advanced international medical technologies into China, Lecheng Pilot Zone is accelerating the aggregation of high-quality resources. The optimized version 3.0 of the special medical device policy in Lecheng will benefit more patients in China, while the Lecheng Special Drug Insurance also ensures the affordability of these medications."
Professor Ma Fei from the National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences, stated: "The results of the DESTINY-Breast03 study indicate that T-DXd can effectively reduce the risk of disease progression or death and significantly improve the objective response rate, establishing a new standard for second-line treatment in HER2-positive breast cancer patients. Thanks to the policy advantages of early adoption and global special drug insurance, we have synchronized with the latest international treatment options, bringing new hope to HER2-targeted therapy in China. We look forward to continuing to benefit more patients in the future."
[References]
1. https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
2. Shui R, Liang X, Li X, et al. Hormone Receptor and Human Epidermal Growth Factor Receptor 2 Detection in Invasive Breast Carcinoma: A Retrospective Study of 12,467 Patients From 19 Chinese Representative Clinical Centers. Clin Breast Cancer. 2020;20(1):e65-e74.
3. Barok M, et al. Trastuzumab emtansine: mechanism of action and drug resistance. Breast Cancer Res. 2014;16(2):209.
4. Mounsey, L et al. Changing Natural History of HER2-Positive Breast Cancer Metastatic to the Brain in the Era of New Targeted Therapies. Clin Breast Cancer. 2018; 18(1):29-37.
5. Martinez-S Sáez O, et al. Current and Future Management of HER2-Positive Metastatic Breast Cancer. JCO Oncol Pract. 2021.10.1200/OP.21.00172.
6. DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03], ClinicalTrials.gov.
According to the data from the large Phase III clinical study DESTINY-Breast03, compared with the previous standard treatment regimen T-DM1, patients who received T-DXd treatment experienced a 72% reduction in the risk of disease progression or death. The investigator-assessed median PFS reached 25.1 months, the objective response rate (ORR) was 79.7%, and the disease control rate exceeded 95%, bringing significant clinical benefits and survival advantages to patients. With its groundbreaking efficacy, T-DXd has redefined the treatment landscape for HER2-positive metastatic breast cancer and has been recommended by international guidelines such as NCCN and ESMO as the standard regimen for second-line treatment of HER2-positive advanced breast cancer.