Datroway, a cancer drug developed by AstraZeneca and Daiichi Sankyo, has demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in the TROPION-Breast02 Phase III trial. The drug offers an alternative to immunotherapy for patients with metastatic triple-negative breast cancer (TNBC).
As per the statement from AstraZeneca and Daiichi, the therapy, which is an antibody drug conjugate (ADC), has the potential to extend overall survival in patients with triple-negative breast cancers who cannot take immunotherapy as compared to the standard chemotherapy. The trial included patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option.
The TROPION-Breast02 study marks a major step forward for a patient group with very limited options. Around 70% of those diagnosed with metastatic TNBC are not eligible for immunotherapy, either because their tumors lack PD-L1 expression or due to other medical factors that restrict treatment. For such patients, chemotherapy has long remained the first-line standard of care, underscoring the importance of Datroway’s results in demonstrating improved overall and progression-free survival outcomes in this setting.
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “Datroway is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic triple-negative breast cancer for whom immunotherapy is not an option. These landmark results from TROPION-Breast02 strengthen our confidence in our ongoing clinical development programme for Datroway in triple-negative breast cancer and other tumour types. We look forward to discussing these data with global regulatory authorities and to bringing Datroway to patients with triple-negative breast cancer as soon as possible.”
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “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. 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.”
