European Commission Expands Gilead’s Trodelvy® Use in First-Line Metastatic TNBC Across PD-L1 Sta

Author : Mary Brown | Published On : 26 Aug 2026

The European Commission has granted expanded authorization for Gilead Trodelvy (sacituzumab govitecan-hziy) in combination with Merck’s Keytruda® (pembrolizumab) for the first-line treatment of adult patients with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC). This decision specifically covers patients with PD-L1-positive tumors displaying a combined positive score (CPS) of 10 or greater who have not received prior systemic therapy for metastatic disease. With this approval, the regimen becomes the first and only antibody-drug conjugate (ADC) combined with immunotherapy cleared for this setting, extending across all 27 European Union member states, as well as Norway, Iceland, and Liechtenstein.

This milestone follows a prior European Commission decision authorizing Trodelvy monotherapy for first-line metastatic TNBC patients who are unsuitable for PD-1 or PD-L1 inhibitor therapies. By securing authorizations across distinct clinical cohorts, Gilead Sciences establishes Trodelvy-based regimens as foundational options for all eligible first-line metastatic TNBC patients regardless of their PD-L1 biomarker status.

Phase 3 ASCENT-04 Trial Demonstrates Superior Progression-Free Survival

The expanded approval relies on positive data from the Phase 3 ASCENT-04 / KEYNOTE-D19 clinical trial. The study evaluated the safety and efficacy of Trodelvy plus Keytruda compared against standard physician-choice chemotherapy combined with Keytruda in patients with previously untreated PD-L1-positive metastatic TNBC.

Results demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). Specifically, the Trodelvy plus Keytruda combination reduced the risk of disease progression or death by 35% compared to standard chemotherapy plus immunotherapy. Principal investigators noted that these findings redefine the first-line standard of care by providing a highly effective, targeted therapeutic backbone early in the treatment journey.

Addressing Critical Unmet Needs in Aggressive Breast Cancer Subtypes

Triple-negative breast cancer represents approximately 15% of all breast cancer diagnoses globally and is recognized as the most aggressive histological subtype. The disease disproportionately affects younger, premenopausal women, as well as Black and Hispanic populations. Because TNBC tumor cells lack estrogen and progesterone receptors and display minimal HER2 expression, traditional targeted endocrine and HER2-directed therapies are ineffective, leaving systemic chemotherapy and targeted ADCs as primary treatment modalities.

Patients diagnosed with metastatic TNBC face a challenging prognosis, with a five-year relative survival rate of just 12%, compared to 28% for other metastatic breast cancer types. Additionally, the average time to metastatic recurrence for TNBC is approximately 2.6 years, nearly half the timeline observed in other breast cancer forms. Establishing potent ADC-based combination therapies in the first-line setting addresses a critical clinical gap, delivering durable disease control before secondary treatment resistance develops.

Expanding Global Impact of Antibody-Drug Conjugates in Oncology

Globally, more than 75,000 patients have been treated with Trodelvy across approved indications, establishing a robust clinical efficacy and safety profile. The European Commission’s approval highlights the growing role of ADCs, which pair tumor-targeted monoclonal antibodies with potent cytotoxic payloads to destroy cancer cells while sparing healthy tissue.

By pairing sacituzumab govitecan's Trop-2 targeting mechanism with pembrolizumab's immune-checkpoint inhibition, the combination strategy delivers a dual-action therapeutic attack. Gilead Sciences continues to evaluate Trodelvy in broader clinical development programs, expanding its oncology portfolio into earlier disease stages and investigating novel combination regimens across multiple solid tumor types.

Discover Health Tech Insiders for the latest advancements in medical technology and trusted strategic insights shaping the future of tech-driven healthcare transformation.