ASCENT-04: Trodelvy + Keytruda Beats Chemo + Immunotherapy as First-Line Treatment in Advanced TNBC

The Phase 3 ASCENT-04/KEYNOTE-D19 trial, published in the New England Journal of Medicine and presented at AACR 2026, showed that sacituzumab govitecan (Trodelvy, an antibody-drug conjugate targeting Trop-2) combined with pembrolizumab (Keytruda) achieved median progression-free survival of 11.2 months compared to 7.8 months for chemotherapy plus pembrolizumab in 443 patients with PD-L1-positive, first-line advanced triple-negative breast cancer (TNBC). Led by Dana-Farber's Dr. Sara Tolaney, the trial demonstrated that replacing the cytotoxic chemotherapy backbone with a precision ADC in combination with immunotherapy delivers meaningfully better outcomes. A regulatory submission is planned to change the first-line standard of care in PD-L1+ advanced TNBC from chemo-immunotherapy to ADC-immunotherapy — the latest step in ADCs displacing conventional chemotherapy in breast cancer.