Datopotamab deruxtecan showed a significant improvement in progression-free survival compared to investigator’s choice chemotherapy. Overall survival did not show statistical significance, possibly due to imbalances in subsequent treatments. The safety profile favored datopotamab deruxtecan with fewer reported adverse events.
Study
|
Randomized, phase 3 study [TROPION-Breast01] |
| Previously treated inoperable/metastatic hormone-receptor-positive HER2-negative breast cancer (progression on endocrine therapy + 1-2 prior lines of chemo) |
| Dato-DXd (n=365) vs ICC (eribulin/capecitabine/vinorelbine/gemcitabine) (n=367)
|
Efficacy
|
ORR: 36.7% vs. 22.1% (Dato-DXd vs. ICC) |
| HR for PFS: 0.63 |
| Median PFS2: 11.7 vs. 10.4 mos (HR: 0.76 [0.63-0.93]) |
| Median OS: 18.6 mos vs. 18.3 mos (HR: 1.01 [0.83-1.22])
|
Safety
|
Grade >=3 TRAEs: 22.2% vs 45.6% |
| Serious TRAEs: 6.1% vs 9.1% |
| Dose discontinuation due to TRAEs: 3.3% vs 2.6% |
| Fatal TRAE (febrile neutropenia): 0% vs 0.3%
|
Ann Oncol. Published online in January 2026
http://doi.org/10.1016/j.annonc.2025.12.017
Reviewed by Ulas D. Bayraktar, MD on Jan 21, 2026
