- Gilead Sciences, Inc. (GILD, Financial) reports positive results from the Phase 3 ASCENT-03 study of Trodelvy® in patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for checkpoint inhibitors.
- The study demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard chemotherapy.
- Trodelvy has the potential to be the backbone treatment for all patients across first-line mTNBC due to its benefits demonstrated in the ASCENT-03 and ASCENT-04 studies.
Gilead Sciences, Inc. (GILD) today unveiled positive topline results from the Phase 3 ASCENT-03 trial for Trodelvy® (sacituzumab govitecan-hziy). This study marks a significant advancement for patients with first-line metastatic triple-negative breast cancer (mTNBC) who cannot undergo PD-1/PD-L1 inhibitor treatments, either due to being PD-L1 negative or ineligibility for immunotherapy.
The ASCENT-03 trial reached its primary endpoint by showing a significant and clinically meaningful improvement in progression-free survival (PFS) when compared to standard chemotherapy treatments. This breakthrough represents the first notable treatment progress in over two decades for this patient group. The safety profile of Trodelvy remained consistent with previous studies, with no new safety signals detected.
Gilead is optimistic about Trodelvy’s potential to serve as the foundational treatment for all patients in the first-line mTNBC setting. The promising outcomes from ASCENT-03, alongside the ASCENT-04 study evaluating Trodelvy in combination with Keytruda® for PD-L1+ mTNBC, support this vision. Further detailed data from ASCENT-04 will be presented at the upcoming American Society of Clinical Oncology (ASCO) meeting.
Despite these advancements, the overall survival (OS) data from ASCENT-03 remains immature, and Gilead plans to continue monitoring and analyzing these outcomes. The drug is also being evaluated in additional Phase 3 trials across various cancer types, reinforcing its position as a critical component in mTNBC treatment strategy.
