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# Promising Trodelvy Data in Breast Cancer: Gilead
- URL: https://www.fdaweb.com/promising-trodelvy-data-in-breast-cancer-gilead/
- Published: 2025-05-23T12:00:00.000Z
- Updated: 2026-09-14T15:12:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159238

Gilead Sciences is announcing promising results from its Phase 3 ASCENT-03 trial evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not eligible for immunotherapy. The data show that Trodelvy significantly improved progression-free survival compared to standard chemotherapy, marking a potential breakthrough for a patient population that has seen limited advancements for decades, according to the company.

The trial’s primary endpoint was met with highly statistically significant and clinically meaningful results, Gilead says. The therapy targets patients with mTNBC who are either PD-L1 negative or otherwise unsuitable for treatment with PD-1/PD-L1 inhibitors. The trial involved approximately 540 patients and compared Trodelvy to physician’s choice chemotherapy, it says. Patients on chemotherapy were allowed to switch to Trodelvy if their disease progressed. Trodelvy, a Trop-2-directed antibody-drug conjugate, is already approved for later-stage mTNBC. The ASCENT-03 results could pave the way for expanding its use into earlier treatment settings.

The company notes that the safety profile of Trodelvy in ASCENT-03 was consistent with prior studies, with no new safety concerns reported. Overall survival data remains immature, but early findings show no detriment, and follow-up is ongoing.