NEJM Publishes ASCENT-03: Sacituzumab Govitecan Improves PFS in PD-1-Ineligible Advanced TNBC

On May 28, 2026, the New England Journal of Medicine published results from the ASCENT-03 Phase 3 randomized controlled trial evaluating sacituzumab govitecan (Trodelvy), a Trop-2-directed antibody-drug conjugate, as monotherapy versus chemotherapy in patients with advanced triple-negative breast cancer (TNBC) not eligible for PD-1/PD-L1 immunotherapy. The trial demonstrated a statistically significant improvement in progression-free survival of 9.7 months versus 6.9 months with chemotherapy (HR 0.66, p<0.001) — a 34% reduction in progression or death risk in a population historically with very limited options following PD-L1-negative or PD-1-contraindicated status. The ASCENT-03 publication follows the April 2026 NEJM publication of ASCENT-04/KEYNOTE-D19, which showed sacituzumab govitecan plus pembrolizumab (11.2 vs. 7.8 months PFS) outperforms chemotherapy plus pembrolizumab in PD-L1+ first-line TNBC — together establishing sacituzumab govitecan as the backbone for first-line TNBC treatment across PD-L1 subgroups. These back-to-back NEJM publications position Trodelvy as the most clinically validated Trop-2 ADC in TNBC and further entrench ADC-first strategies in triple-negative breast cancer, the most aggressive common breast cancer subtype with the fewest actionable targets.