Trodelvy expanded to 1L metastatic TNBC Across PD-L1 Status in the EU

CAR-T Digest - August 2020

Weekly Digest - August 2026

24 August 2026: Trodelvy expanded to 1L metastatic TNBC Across PD-L1 Status in the EU

Gilead announced that the European Commission has approved Trodelvy plus Keytruda for the first-line treatment of adults with unresectable, locally advanced or metastatic TNBC whose tumors are PD-L1 positive (CPS ≥10), following the recent EC approval of Trodelvy monotherapy for patients who are not candidates for PD-1/PD-L1 inhibitors
The approval is based on the phase 3 ASCENT-04/KEYNOTE-D19 trial, where Trodelvy plus Keytruda demonstrated a statistically significant and clinically meaningful improvement in PFS versus standard-of-care chemotherapy plus Keytruda, reducing the risk of disease progression or death by 35% in patients with PD-L1-positive metastatic TNBC
The approval addresses a major unmet need in first-line metastatic TNBC, an aggressive disease with limited treatment options, by providing a Trodelvy-based treatment approach for PD-L1-positive patients eligible for immunotherapy while extending its role beyond later-line treatment
Trodelvy is a Trop-2-directed ADC comprising an antibody linked to SN-38, a topoisomerase I inhibitor payload, through a proprietary hydrolysable linker, enabling targeted payload delivery to Trop-2-expressing tumor cells and a bystander effect within the tumor microenvironment
Strategically, the EU approvals establish Trodelvy as a backbone therapy across first-line metastatic TNBC regardless of PD-L1 status, strengthening Gilead’s position in the early-line TNBC landscape while expanding access to Trodelvy-based treatment across Europe