AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo have announced that their drug Datroway has shown a statistically significant improvement in overall survival for patients with metastatic triple-negative breast cancer (TNBC) who are not eligible for immunotherapy.
The TROPION-Breast02 Phase III study found that Datroway improved both overall survival and progression-free survival compared with standard first-line chemotherapy, marking the first therapy to deliver a survival advantage in this patient population.
Approximately 70% of metastatic TNBC patients are unsuitable for immunotherapy, including those whose tumors lack PD-L1 expression or have other contraindications. Chemotherapy has historically been the standard treatment for these patients.
“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,” stated 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 observed was consistent with previous studies. Both companies plan to present full data at an upcoming medical meeting and submit the findings to regulatory authorities.
Datroway is a TROP2-targeted antibody-drug conjugate being co-developed by AstraZeneca and Daiichi Sankyo. It is currently being tested across multiple stages of TNBC in three additional Phase III trials.
TNBC accounts for around 15% of all breast cancer cases, with roughly 345,000 new diagnoses worldwide 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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