Gilead Sciences, Inc. has announced promising results from the ASCENT-04/KEYNOTE-D19 Phase 3 study, which demonstrated that the combination of Trodelvy® (sacituzumab govitecan-hziy) and Keytruda® (pembrolizumab) reduced the risk of disease progression or death by 35% compared to the standard care of Keytruda plus chemotherapy in patients with first-line PD-L1+ (CPS ≥10) metastatic triple-negative breast cancer (TNBC). The combination therapy led to a median progression-free survival of 11.2 months versus 7.8 months with the standard treatment. These findings suggest Trodelvy's potential as a superior treatment option in this setting, marking the first pivotal trial to show the superiority of a TROP-2 antibody-drug conjugate combined with immunotherapy over standard care. The results will be presented at the 2025 ASCO Annual Congress, with additional investigations ongoing to establish a regulatory pathway for this combination therapy.
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