Positive results from the TROPION-Breast02 phase 3 trial reveal that DATROWAY® (datopotamab deruxtecan) offers a significant improvement in overall survival for patients with metastatic triple negative breast cancer (TNBC). This medication, which is not an option for patients who have previously utilized immunotherapy, demonstrated an unprecedented median overall survival (OS) increase of five months compared to standard chemotherapy. The findings will be presented today during a session at the 2025 European Society for Medical Oncology Congress in Tokyo.
In the trial, DATROWAY showed a median OS of 23.7 months, compared to 18.7 months for patients receiving chemotherapy. The hazard ratio (HR) for overall survival was calculated at 0.79 with a 95% confidence interval (CI) of 0.64-0.98, indicating a statistically significant difference (p=0.0291). Furthermore, DATROWAY reduced the risk of disease progression or death by 43% compared to chemotherapy, with an HR of 0.57 (95% CI: 0.47-0.69; p<0.0001).
Clinical Trial Insights and Safety Profile
The TROPION-Breast02 trial specifically targeted patients with locally recurrent inoperable or metastatic TNBC. This population typically has limited treatment options. As such, the results from this study are particularly promising. DATROWAY is an antibody drug conjugate (ADC) that targets the TROP2 protein, developed by Daiichi Sankyo and AstraZeneca.
While the efficacy results are encouraging, the safety profile of DATROWAY also warrants discussion. Adverse reactions were reported in 100% of patients, with the most common reactions being stomatitis (71%), nausea (50%), and alopecia (49%). Serious complications included interstitial lung disease (ILD) or pneumonitis, which affected 2.4% of participants. Notably, 1.6% of patients experienced fatal adverse reactions, primarily due to unspecified causes.
Further, permanent discontinuation of DATROWAY due to adverse reactions occurred in 8% of patients, with the majority linked to ILD/pneumonitis and abnormal hepatic function. Additionally, dosage interruptions were necessary for 43% of participants, primarily due to COVID-19, stomatitis, and fatigue.
Future Implications for Cancer Treatment
The results from the TROPION-Breast02 trial could reshape treatment paradigms for patients with TNBC, a group often faced with significant challenges in managing their disease. The findings highlight the potential of DATROWAY as a viable first-line treatment option for those who have no immunotherapy alternatives.
Daiichi Sankyo, an innovative global healthcare company, emphasizes a commitment to improving cancer treatment through ongoing research and development. As more data emerges from this trial and others, the landscape of treatment for TNBC may evolve, offering new hope to patients worldwide.
For additional information on adverse reactions or to report suspected side effects, interested parties can contact Daiichi Sankyo at 1-877-437-7763 or visit fda.gov/medwatch.
