Gilead Reports Significant Progression-Free Survival Benefit from Trodelvy Plus Keytruda in Advanced Breast Cancer Study

Gilead Sciences announced positive results from its Phase 3 ASCENT-04/KEYNOTE-D19 trial, where Trodelvy (sacituzumab govitecan-hziy) combined with Keytruda (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with previously untreated, PD-L1+ metastatic triple-negative breast cancer (mTNBC). This is the first pivotal trial to show the superiority of a TROP-2 antibody-drug conjugate plus immunotherapy over standard Keytruda-chemotherapy combinations.

The study met its primary endpoint and showed early trends toward improved overall survival. No new safety signals were observed. These findings suggest a potentially practice-changing treatment option for patients with this aggressive cancer type.

Detailed data will be presented at an upcoming medical conference. The combination is investigational for this use, and Gilead plans further discussions with regulators. Gilead continues to study Trodelvy across various cancers and stages through multiple ongoing Phase 3 trials.