EU approves Gilead's Trodelvy combo, cutting TNBC progression risk 35%

The European Commission approved Gilead's Trodelvy plus Merck's Keytruda for first-line PD-L1-positive metastatic triple-negative breast cancer, cutting progression risk 35 percent.

"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," Evandro de Azambuja, MD, PhD, Head of the Medical Support Team at Jules Bordet Institute and investigator of the ASCENT-04 study, said.

The approval is based on the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which randomized 443 patients. Median progression-free survival was 11.2 months with Trodelvy plus Keytruda versus 7.8 months with chemotherapy plus Keytruda, a hazard ratio of 0.65 (95% CI, 0.51–0.84; P<0.001). Objective response rate was 60 percent versus 53 percent, with median duration of response of 16.5 months versus 9.2 months. Overall survival data were immature at the time of analysis.

The decision follows the EC's June 23 approval of Trodelvy as monotherapy for first-line metastatic TNBC patients ineligible for PD-1/PD-L1 inhibitors, establishing the ADC as a backbone therapy across PD-L1 status in Europe. The combination is the first ADC plus immunotherapy regimen approved for first-line metastatic TNBC in the EU's 27 member states, as well as Norway, Iceland and Liechtenstein.

TNBC accounts for approximately 15 percent of all breast cancers and disproportionately affects younger, premenopausal, and Black and Hispanic women. Among women with metastatic TNBC, the five-year survival rate is 12 percent, compared with 28 percent for other types of metastatic breast cancer.

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody-drug conjugate designed with a hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. More than 75,000 breast cancer patients have been treated with Trodelvy globally since 2020. The U.S. FDA approved the drug for first-line metastatic TNBC on June 24, 2026, both as monotherapy and in combination with pembrolizumab.

Grade 3 or higher adverse events occurred in 71 percent of patients receiving Trodelvy plus Keytruda and 70 percent of those receiving chemotherapy plus Keytruda. Adverse events led to treatment discontinuation in 12 percent and 31 percent of patients, respectively, while adverse events leading to death occurred in 3 percent of patients in each group. Trodelvy carries a boxed warning for severe neutropenia and diarrhea.

"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," Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences, said.

The approval expands Gilead's addressable market for Trodelvy into the first-line setting, where the drug previously competed only in later lines of therapy. Investors will watch European launch uptake and reimbursement decisions across member states, as well as ongoing Phase 3 trials evaluating Trodelvy in lung and gynecologic cancers.

This article is for informational purposes only and does not constitute investment advice.