EU approves Gilead's Trodelvy combo with Keytruda for front-line TNBC

Gilead Sciences (NASDAQ: GILD) announced that the European Commission has granted marketing authorization for Trodelvy (sacituzumab govitecan-hziy) in combination with Keytruda (pembrolizumab) for 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 of at least 10.

The approval covers the EU's 27 member states, as well as Norway, Iceland and Liechtenstein. It follows a separate EC approval of Trodelvy as monotherapy for first-line metastatic TNBC patients who are not candidates for PD-1 or PD-L1 inhibitor therapy.

The combination approval is based on data from the Phase 3 ASCENT-04/KEYNOTE-D19 study, which showed a 35% reduced risk of disease progression or death in patients with PD-L1-positive metastatic TNBC compared with standard-of-care chemotherapy plus Keytruda.

Keytruda is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co.

TNBC accounts for approximately 15% of all breast cancers. The five-year survival rate among women with metastatic TNBC is 12%, compared with 28% for other types of metastatic breast cancer, according to the press release.

Gilead states that more than 75,000 breast cancer patients have been treated with Trodelvy globally since 2020. The drug is also approved in the United States for first-line metastatic TNBC, both as monotherapy and in combination with pembrolizumab, as well as for second-line and later metastatic TNBC and pre-treated hormone receptor-positive, HER2-negative metastatic breast cancer.

Trodelvy carries a boxed warning for severe neutropenia and diarrhea. Common adverse reactions in the ASCENT-04 combination study included decreased neutrophil and hemoglobin counts, diarrhea, nausea, fatigue, and alopecia.

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