Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca, has been recommended for approval in the European Union for treating advanced hormone receptor-positive, HER2-negative breast cancer in adults who have received prior endocrine therapy and chemotherapy. The positive opinion from the CHMP is based on the TROPION-Breast01 phase 3 trial, which demonstrated Dato-DXd significantly improved progression-free survival and objective response rates compared to standard chemotherapy. The European Commission will now review the CHMP recommendation and decide on marketing authorization.
This potential approval is crucial for patients with HR-positive, HER2-negative metastatic breast cancer who experience disease progression after standard endocrine therapy and chemotherapy. Current treatment options in this setting offer limited efficacy and often come with significant side effects. Dato-DXd provides a new therapeutic approach with a demonstrated ability to extend progression-free survival and increase response rates, potentially improving patient outcomes and quality of life.
In the TROPION-Breast01 trial, Dato-DXd reduced the risk of disease progression or death by 37% compared to chemotherapy. Patients treated with Dato-DXd had a median progression-free survival of 6.9 months versus 4.9 months for those receiving chemotherapy. The objective response rate was also higher in the Dato-DXd arm (36%) compared to the chemotherapy arm (23%). Importantly, the safety profile of Dato-DXd was favorable, with fewer grade 3 or higher treatment-related adverse events compared to chemotherapy.
The anticipated EU approval of Dato-DXd marks a significant advancement in the treatment landscape for advanced HR-positive, HER2-negative breast cancer. This new targeted therapy offers a promising alternative to conventional chemotherapy, potentially leading to better outcomes for patients who currently have limited effective treatment choices. This approval could also pave the way for further research exploring Dato-DXd’s potential in other breast cancer subtypes and in combination with other therapies.
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.