Gilead Sciences announced that the European Commission (EC) has granted Marketing Authorisation (MA) for 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).

Trodelvy plus Keytruda is the first and only Antibody Drug Conjugate (ADC) plus immunotherapy combination to be approved in first-line metastatic TNBC in the European Union’s (EU) 27 member states, as well as Norway, Iceland and Liechtenstein.

This decision follows the recent EC approval of Trodelvy as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Together, these approvals establish Trodelvy as the backbone therapy for patients with first-line metastatic TNBC across PD-L1 status in Europe. This decision provides a new treatment option for the most aggressive form of breast cancer at the first sign of metastatic disease.

Evandro de Azambuja, MD, PhD, Head of the Medical Support Team, Jules Bordet Institute and investigator of the ASCENT-04 study, said, “The approval of Trodelvy plus Keytruda represents a meaningful advance in the treatment of patients with PD-L1-positive metastatic TNBC. This regimen helps redefine a Standard of Care (SoC) by offering a novel first-line treatment option for a metastatic patient population with a particularly aggressive form of breast cancer.”

The approval is based on data from the phase 3 ASCENT-04/KEYNOTE-D19 study which demonstrated a highly statistically significant and clinically meaningful Progression-Fee Survival (PFS) of Trodelvy plus Keytruda versus the combination of SoC chemotherapy plus Keytruda as a first-line treatment. In ASCENT-04/KEYNOTE-D19, Trodelvy demonstrated a 35 percent reduced risk of disease progression or death in patients with PD-L1-positive metastatic TNBC.

Mika Kakefuda Derynck, MD, Senior Vice President (SVP), Clinical Development, Oncology, Gilead Sciences, said, “Today’s approval transforms the treatment landscape for all patients with first-line metastatic TNBC. 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.”

Metastatic TNBC has historically been difficult to treat, with a poor prognosis and an urgent need for more effective first-line options. With today's approval, Trodelvy is now positioned to address this need across the full spectrum of the disease, building on its extensive clinical legacy in later lines of therapy and its established safety and efficacy profile in more than 75,000 patients treated globally.

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC., a subsidiary of Merck and Co., Inc., Rahway, NJ, USA.