Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab), for the treatment of 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 European Commission decision on this indication is anticipated later in 2026.

Metastatic TNBC is an aggressive form of breast cancer that is associated with rapid disease progression and poor prognosis. Approximately 40% of metastatic TNBC tumors are PD-L1 positive. These tumors are considered more aggressive and associated with shorter survival, creating urgency to initiate treatment with effective regimens as soon as possible. For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment.

"People with metastatic triple-negative breast cancer need effective treatment options as early as possible in the course of their disease, particularly when their tumors express PD-L1," said Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and Investigator of the ASCENT-04 study. "This positive opinion is welcome news for our patients and the entire clinical community. If authorized, Trodelvy plus Keytruda would build on the recent approval of Trodelvy monotherapy and help establish a Trodelvy-based approach as a first-line treatment option for patients with metastatic triple-negative breast cancer across PD-L1 status."

The CHMP’s recommendation is based on data from the Phase 3 ASCENT-04 study/KEYNOTE-D19 which demonstrated a highly statistically significant and clinically meaningful progression-free survival of Trodelvy plus Keytruda versus the combination of standard of care chemotherapy plus Keytruda as a first-line treatment in PD-L1 positive patients. In ASCENT-04/KEYNOTE-D19, Trodelvy plus Keytruda demonstrated a 35% reduced risk of disease progression or death in patients with PD-L1 positive metastatic TNBC. The ASCENT-04/KEYNOTE-D19 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed.