The European Commission has granted approval for the combination of Gilead Sciences’ Trodelvy and Merck’s Keytruda to treat adult patients with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC) in the EU, Norway, Iceland, and Liechtenstein.
The approval applies to patients who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 with a combined positive score of 10 or higher. Trodelvy was also recently authorized as a monotherapy for TNBC patients ineligible for PD-1 or PD-L1 inhibitor therapy.
The decision follows positive results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed the Trodelvy-Keytruda combination reduced the risk of disease progression or death by 35% compared with standard chemotherapy plus Keytruda in PD-L1-positive metastatic TNBC patients.
Triple-negative breast cancer represents approximately 15% of all breast cancer cases and is the most aggressive subtype, with a five-year survival rate of just 12% for metastatic patients. The condition disproportionately affects younger, premenopausal women, as well as Black and Hispanic women.
Since its initial approval in 2020, more than 75,000 breast cancer patients have been treated with Trodelvy. Gilead Sciences and Merck Sharp & Dohme LLC will market the combination under their respective brands.
