The FDA approved Merck’s KEYTRUDA in combination with Gilead’s Trodelvy for advanced triple-negative breast cancer (TNBC). This approval applies to adult patients whose tumors express PD-L1. It represents the first time a PD-1 inhibitor has been approved with a Trop-2-directed antibody-drug conjugate (ADC) for this indication.
The decision followed the Phase 3 KEYNOTE-D19/ASCENT-04 trial. The combination therapy reduced the risk of disease progression or death by 35% compared to KEYTRUDA plus chemotherapy.
This regimen offers a new first-line treatment option for this aggressive cancer type. Historically, patients with advanced TNBC have had limited therapeutic options.