Trodelvy® Plus Keytruda® Reduces Risk of Disease Progression or Death by 35% Versus Keytruda and Chemotherapy in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer

CAR-T Digest - August 2020

Weekly Digest - June 2025

31 May 2025: Trodelvy plus Keytruda reduces risk of disease progression or death by 35% versus Keytruda and chemotherapy in first-line PD-L1+ metastatic triple-negative breast cancer

Gilead reported that Trodelvy (Sacituzumab govitecan) plus Keytruda significantly improved progression-free survival (PFS) in PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC) patients, reducing the risk of disease progression or death by 35% compared to Keytruda plus chemotherapy
The Phase 3 ASCENT-04/KEYNOTE-D19 study showed a median PFS of 11.2 months with the Trodelvy-Keytruda combination versus 7.8 months with Keytruda plus chemotherapy, with consistent PFS benefits across key patient subgroups
Higher overall and complete response rates were observed with Trodelvy plus Keytruda, along with a notably longer duration of response (16.5 vs. 9.2 months), indicating potential clinical superiority over the current standard
These findings support a potential new frontline standard of care for PD-L1+ metastatic TNBC, while additional data from the ASCENT-03 trial in PD-1/PD-L1–ineligible patients will further inform regulatory discussions and development strategy