Datroway (datopotamab deruxtecan-dlnk, Dato-Dxd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate co-developed by Japan-based Daiichi Sankyo (TYO: 4568) and UK major AstraZeneca (AZ, NASDAQ: AZN), last week received approval from the US FDA for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer. These patients have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval follows a similar marketing nod in Japan for previously treated HR+/HER2- breast cancer last month.
Clinical Trial Results
The multi-center, open-label, randomized TROPION-Breast01 study demonstrated that compared to the chemotherapy group, the Dato-Dxd treatment group showed significant improvements in progression-free survival (mPFS: 6.9 months vs 4.9 months), overall response rate (ORR: 36% vs 23%), and duration of response (mDOR: 6.7 months vs 5.7 months). While there was no statistically significant difference in overall survival between the two groups (mOS: 18.6 months vs 18.3 months), Dato-Dxd exhibited good overall tolerability.
Significance of the Approval
This FDA approval marks a significant milestone for Datroway, offering a new treatment option for patients with advanced breast cancer who have limited therapeutic choices. The collaboration between Daiichi Sankyo and AstraZeneca highlights the ongoing efforts to address unmet medical needs in oncology through innovative therapies.-Fineline Info & Tech
