Gilead Bolsters Trodelvy in Triple-Negative Breast Cancer With Practice-Changing Keytruda Combo Win

Gilead's Trodelvy (sacituzumab govitecan-hziy) combined with Merck's Keytruda (pembrolizumab) significantly lowered the risk of disease progression or death by 35% compared to Keytruda plus chemotherapy in first-line treatment for PD-L1 positive metastatic triple-negative breast cancer (TNBC)345.

Patients receiving Trodelvy plus Keytruda achieved a median progression-free survival (PFS) of 11.2 months, compared to 7.8 months for those on Keytruda plus chemotherapy34.

These results come from the pivotal phase 3 ASCENT-04/KEYNOTE-D19 trial, the first study to show superiority of a TROP-2 antibody-drug conjugate (Trodelvy) combined with an immunotherapy (Keytruda) over standard of care in newly diagnosed metastatic TNBC45.

An early trend toward improved overall survival was observed, with an 11% preliminary reduction in risk of death, though overall survival data are still immature34.

The findings, described as 'practice-changing' by oncology experts, will be presented at the 2025 ASCO Annual Meeting and could redefine the front-line standard of care for this aggressive breast cancer subtype345.

Sources:

3. https://www.fiercepharma.com/pharma/gilead-bolsters-trodelvy-triple-negative-breast-cancer-practice-changing-keytruda-combo-win

4. https://www.gilead.com/news/news-details/2025/trodelvy-plus-keytruda-reduces-risk-of-disease-progression-or-death-by-35-versus-keytruda-and-chemotherapy-in-first-line-pd-l1-metastatic-triple-negative-breast-cancer

5. https://www.appliedclinicaltrialsonline.com/view/gilead-trodelvy-keytruda-significantly-improves-progression-free-survival-pd-l1-positive-metastatic-triple-negative-breast-cancer