AstraZeneca and Daiichi Sankyo's Datroway Achieves Landmark Results in Triple-Negative Breast Cancer Trial
AstraZeneca and Daiichi Sankyo have announced groundbreaking results for their antibody-drug conjugate (ADC) Datroway in the treatment of triple-negative breast cancer (TNBC), marking a significant advancement in the field of oncology.
Breakthrough in Triple-Negative Breast Cancer Treatment
In a phase 3 trial, Datroway demonstrated statistically significant and clinically meaningful improvements in both overall survival (OS) and progression-free survival (PFS) compared to standard chemotherapy. This achievement marks the first time a cancer drug has shown an overall survival benefit against chemotherapy for patients with locally recurrent inoperable or metastatic TNBC who are ineligible for immunotherapy.
Susan Galbraith, AstraZeneca's head of oncology and hematology R&D, stated, "We expect today's results will mark an inflection point in the treatment of these patients who have the poorest prognosis of any type of breast cancer and urgently need better options."
The trial, known as TROPION-Breast02, focused on patients for whom immunotherapy is not an option, representing approximately 70% of TNBC cases. TNBC accounts for 15% of breast cancer cases and is known for its aggressive nature and poor prognosis, with a median overall survival rate of 12 to 18 months and only 14% of patients surviving five years post-diagnosis.
Datroway's Mechanism and Potential Impact
Datroway, designed to target the TROP2 protein found on the surface of tumor cells in many cancer types, is part of a class of targeted therapies known as antibody-drug conjugates. This approach allows for more precise targeting of cancer cells while potentially reducing damage to healthy tissues.
Ken Takeshita, Daiichi Sankyo's global head of research and development, emphasized the significance of these results, stating they could pave the way for Datroway to become a new treatment option for a substantial portion of TNBC patients currently limited to chemotherapy as their standard of care.
The companies plan to present detailed data from the TROPION-Breast02 trial at an upcoming medical meeting and submit the findings to global health regulators "as soon as possible."
Expanding Datroway's Therapeutic Reach
Datroway's success in TNBC adds to its growing list of indications. The drug received its first FDA approval in January 2025 for previously treated metastatic, HR-positive, HER2-negative breast cancer. In June of the same year, the FDA expanded its label to include treatment for patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).
AstraZeneca and Daiichi Sankyo are further exploring Datroway's potential in combination with AstraZeneca's PD-L1 inhibitor Imfinzi across three additional phase 3 studies in various stages and treatment settings of TNBC.
The collaboration between AstraZeneca and Daiichi Sankyo on Datroway began in 2020 with a $1 billion upfront payment from AstraZeneca, with an additional $5 billion tied to potential regulatory and sales milestones. AstraZeneca has projected Datroway's annual peak sales potential at $5 billion.
References
- AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer
The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.
- AZ, Daiichi score 'landmark' results for ADC Datroway in triple-negative breast cancer
AstraZeneca and Daiichi Sankyo’s Datroway has become the first cancer drug to show an overall survival benefit against chemotherapy for certain patients with a particularly aggressive form of breast cancer. In a phase 3 trial, the antibody-drug conjugate has scored as a first-line treatment for those with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy is not an option.
Explore Further
What specific adverse events or safety concerns, if any, were observed during the TROPION-Breast02 trial for Datroway?
Who are the major competitors currently developing or marketing treatments for triple-negative breast cancer patients, and how do their approaches differ from Datroway?
What is the estimated market size for therapies targeting triple-negative breast cancer, especially in cases where immunotherapy is not an option?
How does Datroway's mechanism of targeting the TROP2 protein compare to other antibody-drug conjugates currently in development or on the market?
What are the anticipated timelines for regulatory submissions and potential FDA approval for Datroway in the triple-negative breast cancer indication?