The ASCENT-03 trial demonstrated that sacituzumab govitecan significantly improved progression-free survival compared to chemotherapy in patients with untreated, advanced triple-negative breast cancer not eligible for immunotherapy. The incidence of grade 3 or higher adverse events was similar between the two treatment groups, but sacituzumab govitecan resulted in fewer treatment discontinuations.
Study
|
International, phase 3, open-label, randomized trial [ASCENT-03] |
| Previously untreated, advanced triple-negative breast cancer patients not candidates for PD-1/PD-L1 inhibitors |
| Sacituzumab govitecan (n=279) vs Chemotherapy (n=279)
|
Efficacy
|
ORR: 48% vs 46% |
| mPFS: 9.7 mos vs 6.9 mos (HR 0.62 [0.50-0.77]) |
| mOS: 21.5 mos vs 20.2 mos
|
Safety
|
Grade >=3 AE: neutropenia (43% vs 41%), diarrhea (9% vs 1%), leukopenia (7% vs 13%) |
| Serious AEs: 26% vs 24% |
| Treatment discontinuation: 4% vs 12%
|
N Engl J Med. Published online October 19, 2025.
http://doi.org/10.1056/NEJMoa2511734
Reviewed by Ulas D. Bayraktar, MD on Nov 14, 2025
