Gilead reports ASCENT-04/KEYNOTE-D19 study met primary endpoint

Gilead Sciences (GILD) announced topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy plus Keytruda significantly improved progression-free survival compared to Keytruda and chemotherapy in patients with inoperable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS. The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with the known safety profile of each agent. No new safety signals were identified with the combination. “These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “For patients with this difficult to treat type of breast cancer, these results potentially offer a new pathway that may redefine their treatment options.” Keytruda is a registered trademark of Merck Sharp & Dohme, a subsidiary of Merck (MRK).