Gilead announces ASCENT-03 study meets primary endpoint

Gilead (GILD) announced topline results from the Phase 3 ASCENT-03 study of Trodelvy. The study met its primary endpoint, demonstrating a highly statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy in patients with first-line metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitors, meaning they are PD-L1 negative or are ineligible to receive immunotherapy. The safety profile of Trodelvy in the ASCENT-03 study was consistent with prior studies, and no new safety signals were identified in this patient population. Overall survival is a key secondary endpoint and was not mature at the time of PFS primary analysis. No OS detriment was observed. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analysis planned. Detailed results from the ASCENT-03 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.