The European Commission has approved Trodelvy (sacituzumab govitecan) in combination with pembrolizumab for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score (CPS ≥10). The decision makes the regimen the first antibody-drug conjugate (ADC) plus immunotherapy combination approved in first-line metastatic TNBC across the EU's 27 member states, Norway, Iceland, and Liechtenstein.
The combination approval follows a recent EC decision permitting Trodelvy monotherapy for first-line metastatic TNBC patients who are not candidates for PD-1 or PD-L1 inhibitor therapy. Together, Gilead Sciences (Nasdaq: GILD) said, the two approvals position Trodelvy as the backbone treatment for first-line metastatic TNBC regardless of PD-L1 status in Europe.
The combination approval is based on the Phase III ASCENT-04/KEYNOTE-D19 trial, which evaluated Trodelvy plus pembrolizumab against standard-of-care chemotherapy plus pembrolizumab as first-line treatment in PD-L1-positive metastatic TNBC. The study reported a statistically significant improvement in progression-free survival, with Trodelvy demonstrating a 35% reduced risk of disease progression or death compared with the chemotherapy-based control arm, Gilead said.