AstraZeneca (LSE:AZN) and Daiichi Sankyo have reported that Datroway demonstrated a statistically significant improvement in overall survival for patients with metastatic triple-negative breast cancer (TNBC) who are ineligible for immunotherapy.
The TROPION-Breast02 Phase III trial showed that the drug improved both overall survival and progression-free survival compared with chemotherapy as a first-line treatment. This represents the first therapy to show a survival benefit in this specific patient population.
Around 70% of patients with metastatic TNBC are not candidates for immunotherapy, including those whose tumors do not express PD-L1 or who cannot receive it for other reasons. For these patients, chemotherapy has been the standard first-line therapy.
“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.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, added that Datroway is “the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy” in this patient group.
The safety profile was consistent with prior clinical trials. Detailed data will be presented at an upcoming medical meeting and shared with regulatory authorities.
Datroway is a TROP2-directed antibody drug conjugate being jointly developed by AstraZeneca and Daiichi Sankyo. The companies are evaluating it across multiple stages of TNBC in three additional Phase III trials.
TNBC represents about 15% of all breast cancer cases, with roughly 345,000 new diagnoses globally each year. It is the most aggressive form of breast cancer, with a median overall survival of just 12 to 18 months.
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