Gilead Trodelvy has gained expanded European approval for first-line treatment of metastatic triple-negative breast cancer (TNBC). The European Commission has authorized Trodelvy® with Keytruda® for eligible patients with PD-L1-positive disease.
The approval covers adults with unresectable, locally advanced, or metastatic TNBC. These patients must not have received prior systemic therapy for metastatic disease. Their tumors must also show PD-L1 expression with a combined positive score of at least 10. The decision gives Gilead Trodelvy an important role in first-line metastatic TNBC treatment. It also expands the treatment options available to patients across Europe.
The European Commission approved Trodelvy® (sacituzumab govitecan-hziy) with Keytruda® (pembrolizumab). The combination targets adults with PD-L1-positive metastatic TNBC. Trodelvy plus Keytruda becomes the first and only ADC plus immunotherapy combination approved for this setting. The authorization applies across the European Union’s 27 member states. It also covers Norway, Iceland, and Liechtenstein. Therefore, the decision expands access across a broad European patient population.
The latest approval follows an earlier European Commission decision. That decision approved Trodelvy as monotherapy for specific patients with metastatic TNBC. Those patients must not have received prior systemic therapy for metastatic disease. They must also remain unsuitable for PD-1 or PD-L1 inhibitor treatment. Together, the approvals strengthen Trodelvy’s position in first-line metastatic TNBC. Gilead Sciences now offers Trodelvy-based options across PD-L1 status.
“The approval of Trodelvy plus Keytruda represents a meaningful advance in the treatment of patients with PD-L1-positive metastatic TNBC,” said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and investigator of the ASCENT-04 study. “This regimen helps redefine a standard of care by offering a novel first-line treatment option for a metastatic patient population with a particularly aggressive form of breast cancer.”
ASCENT-04 Study Supports the Decision
The European authorization relies on results from the Phase 3 ASCENT-04 / KEYNOTE-D19 study. The trial evaluated Trodelvy plus Keytruda as a first-line treatment. The study compared the combination against standard chemotherapy plus Keytruda. Results showed a statistically significant improvement in progression-free survival. The findings also demonstrated a clinically meaningful treatment benefit. Trodelvy reduced the risk of disease progression or death by 35%.
This result came from patients with PD-L1-positive metastatic TNBC. Consequently, the data supported the combination’s role in earlier treatment. The study adds to Trodelvy’s clinical evidence in metastatic breast cancer. It also supports Gilead’s strategy of expanding the medicine into earlier treatment settings.
“Today’s approval transforms the treatment landscape for all patients with first-line metastatic TNBC,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “With Trodelvy-based options now approved in the EU for all eligible first-line metastatic TNBC patients across PD-L1 status, we have established a new, much-needed backbone therapy. This is an important milestone for patients who need new options earlier in their treatment journey.”
Trodelvy Addresses an Unmet TNBC Treatment Need
Metastatic TNBC remains one of the most challenging breast cancer types to treat. Patients often face a poor prognosis and limited treatment options. The latest approval could provide an important option earlier in the treatment journey. Meanwhile, Trodelvy builds on its established clinical experience in later-line treatment.
Gilead Sciences reported that more than 75,000 patients have received Trodelvy globally. The medicine also has an established safety and efficacy profile. The European decision therefore represents another milestone for Gilead Sciences. It expands the role of Trodelvy in first-line metastatic TNBC treatment. The approval also highlights the growing importance of antibody-drug conjugates. These medicines combine targeted approaches with cancer-killing therapies.
Furthermore, combining an ADC with immunotherapy could broaden treatment strategies. Such approaches remain important as researchers seek better outcomes for metastatic TNBC.
Understanding Triple-Negative Breast Cancer
Triple-negative breast cancer is considered the most aggressive type of breast cancer. It represents approximately 15% of all breast cancer cases. TNBC can disproportionately affect younger and premenopausal women. Black and Hispanic women also experience a higher impact from the disease. TNBC cells lack estrogen and progesterone receptors. They also have limited HER2 expression.
These characteristics restrict the treatment approaches available to patients. As a result, treatment options remain more limited than those for other breast cancer types. TNBC also carries a higher risk of recurrence and metastasis. The average time to metastatic recurrence stands at approximately 2.6 years.
For other breast cancer types, the average period reaches about five years. Survival outcomes also remain lower among patients with metastatic TNBC. Among women with metastatic TNBC, the five-year survival rate is 12%. For other types of metastatic breast cancer, the rate reaches 28%.
Therefore, new first-line treatment options remain a major clinical need. The expanded European approval of Gilead Trodelvy could help address that need. The decision further strengthens Trodelvy’s role across the first-line metastatic TNBC treatment landscape. It also gives eligible patients another option at the start of metastatic treatment.
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News Source: Businesswire.com
