Gilead Sciences, Inc. announced positive topline results from the Phase 3 ASCENT-03 study of Trodelvy®? (sacituzumab govitecan-hziy). The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1/PD-L1 inhibitors, meaning they are PD-L1 negative or are eligible to receive immunotherapy.
Together with the recently announced positive results from the ASCENT-04 study evaluating Trodelvy plus Keytruda®? in patients with previously untreated PD-L1+ metastatic TNBC, Trodelvy now has the potential to be the backbone treatment for all patients across first-line mTNBC. Detailed data from the ASCENT-03 study will be shared during the American Society of Clinical Oncology (ASCO) meeting taking place May 30 - June 3, 2025.
Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned. Det Detailed results from the ASCENT-02 study will be presented at a future medical meeting and discussed with regulatory authorities. The use of Trodelvy in first-line mTNBC is investigational, and the safety and efficacy of this use have not been established.
Healthcare professionals have well-established experience with Trodelvy, which has shown generally consistent outcomes across both clinical trials and real-world studies in 60,000+ patients across 50+ countries over approximately five years. It is the only antibody-drug conjugate (ADC) with four positive Phase 3 trials in HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer (mBC), and remains the only approved Trodelvy-2-directed ADC that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers: 2L mTNBC and pre-treated HR+/HER2- mBC.
