Gilead eyes earlier use of Trodelvy in TNBC as Phase III hits key goal

Title

Gilead Advances Trodelvy to Earlier Triple-Negative Breast Cancer Use as Phase III Trial Achieves Key Milestone

Gilead's Trodelvy (sacituzumab govitecan) has shown significant efficacy in treating metastatic triple-negative breast cancer (TNBC), particularly in patients who have received two or more prior systemic therapies5.
In the Phase III ASCENT study, Trodelvy reduced the risk of disease progression or death by 57% (improving median PFS from 1.7 to 4.8 months) and decreased the risk of death by 49% (improving median OS from 6.9 to 11.8 months) compared to standard chemotherapy5.
Newer data demonstrate that Trodelvy provides survival benefit regardless of a patient's initial breast cancer subtype, even for those whose disease later converts to TNBC1.
Trodelvy is the first treatment in metastatic TNBC to show clear overall survival benefits in a Phase III setting5.
The recent Phase III trial (ASCENT-04/Keynote-D19) showed that combining Trodelvy with Keytruda (pembrolizumab) as a first-line therapy for metastatic TNBC led to improved outcomes over the current standard of Keytruda with chemotherapy in patients whose tumors express PD-L13.
These findings mark the first time an antibody-drug conjugate (Trodelvy) combined with an immuno-oncology agent (Keytruda) demonstrated superiority to standard care in first-line TNBC treatment3.
Trodelvy is currently approved in the U.S. for unresectable locally advanced or metastatic TNBC in adults after at least two prior therapies, but these new results support moving its use to earlier lines of treatment5 4.