Gilead’s Trodelvy Achieves Primary Endpoint in Phase III Breast Cancer Trial

Gilead Sciences’ global Phase III ASCENT-03 trial of Trodelvy (sacituzumab govitecan) met its primary goal, showing improved progression-free survival (PFS) versus chemotherapy in first-line metastatic triple-negative breast cancer (mTNBC) patients who are PD-L1 negative or ineligible for immunotherapy. Nearly 540 patients were randomized to receive Trodelvy or physician’s choice chemotherapy, continuing treatment until disease progression or unacceptable toxicity. Chemotherapy patients could crossover to Trodelvy upon progression.

The safety profile aligned with prior studies, with no new safety concerns. Although overall survival data remain immature, no detriment was observed. Detailed results will be presented at the ASCO meeting in May 2025. Gilead is also conducting additional Phase III trials of Trodelvy in various breast cancer subtypes and other cancers.

28-05-2025