Datopotamab deruxtecan (DATROWAY), a TROP2-directed antibody-drug conjugate (ADC), has received US approval for treating adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer. Developed jointly by Daiichi Sankyo and AstraZeneca, DATROWAY is indicated for patients who have undergone prior endocrine-based therapy and chemotherapy. This approval follows positive results from the TROPION-Breast01 phase 3 trial, where DATROWAY significantly improved progression-free survival compared to chemotherapy.
This approval addresses a significant unmet need for patients with HR-positive, HER2-negative metastatic breast cancer. Current treatment options after endocrine therapy and initial chemotherapy often yield limited responses. DATROWAY offers a new therapeutic approach with the potential to improve outcomes for this patient population, particularly those who have progressed after standard treatments. This is crucial given that only about 30% of patients with metastatic breast cancer survive five years after diagnosis.
In the TROPION-Breast01 trial, DATROWAY demonstrated a 37% reduction in the risk of disease progression or death compared to chemotherapy. The median progression-free survival was 6.9 months with DATROWAY versus 4.9 months with chemotherapy. Additionally, DATROWAY showed a higher objective response rate of 36% compared to 23% in the chemotherapy arm. However, the treatment also carries risks, with common adverse reactions including stomatitis, nausea, fatigue, and ocular issues. More serious adverse reactions like interstitial lung disease and pneumonitis were also observed, requiring careful patient monitoring.
The approval of DATROWAY represents a significant step forward in breast cancer treatment. This new ADC offers a novel mechanism of action and the potential to improve outcomes for patients who have exhausted other therapeutic avenues. It strengthens the position of both Daiichi Sankyo and AstraZeneca in the oncology market and suggests a growing role for ADCs in targeted cancer therapies. Further research and real-world data will be crucial in confirming the long-term benefits and safety profile of DATROWAY.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
