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LONDON - AstraZeneca PLC (LSE:AZN) and Daiichi Sankyo announced Monday that their antibody drug conjugate Datroway (datopotamab deruxtecan) demonstrated statistically significant improvements in both overall survival and progression-free survival compared to chemotherapy in a Phase III trial for metastatic triple-negative breast cancer patients.
The TROPION-Breast02 trial evaluated Datroway as a first-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer for whom immunotherapy was not an option, representing approximately 70% of patients with this aggressive cancer type.
According to the companies, this marks the first time any therapy has shown an overall survival benefit in this specific patient population, for whom chemotherapy has remained the standard of care.
"TROPION-Breast02 is the only trial ever to show an overall survival benefit in the first-line treatment of patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option," said Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca.
The safety profile of Datroway was consistent with previous clinical trials in breast cancer, according to the press release statement. The companies plan to present detailed results at an upcoming medical meeting and share the data with regulatory authorities.
Datroway is a TROP2-directed antibody drug conjugate that was discovered by Daiichi Sankyo and is being jointly developed and commercialized by both companies. The drug is already approved in over 35 countries for certain patients with HR-positive, HER2-negative breast cancer, and in the United States for specific EGFR-mutated non-small cell lung cancer patients.
Triple-negative breast cancer accounts for approximately 15% of all breast cancer cases and has the worst prognosis among breast cancer types, with median overall survival of just 12 to 18 months.
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