“we have submitted two supplemental biologics license applications for Trodelvy in first-line metastatic TNBC and expect regulatory decisions in 2026.”

In context

“nhibitors. Specifically, Trodelvy demonstrated a 9.7 months median progression-free survival compared to 6.9 months for standard of care chemotherapy. This reflects a statistically significant and clinically meaningful 38% reduction in disease progression or death versus standard of care chemotherapy. As we expected when we initiated the study, the median overall survival data are not yet mature. These results were simultaneously published in the New England Journal of Medicine. Additionally, the detailed results from ASCENT-04 were shared at the ASCO meeting in May. These data, combined with ASCENT-03, highlight the potential for Trodelvy to be a backbone treatment across first-line metastatic triple-negative breast cancer. Based on these positive Phase III updates from ASCENT-03 and 04, we have submitted two supplemental biologics license applications for Trodelvy in first-line metastatic TNBC and expect regulatory decisions in 2026. This is incredibly important for patients as metastatic TNBC is the most aggressive subtype of breast cancer with limited treatment options and poor prognosis. Historically, progress in first-line therapy has been minimal and nearly half of patients do not progress beyond first-line treatment, meaning they may never access Trodelvy if it remains a later-line option. Similarly, we are currently exploring Trodelvy for first-line post-endocrine hormone receptor positive HER2-negative metastatic breast cancer patients in the Phase III ASCENT-07 trial. We now expect to provide an update from this trial before the end of the year. On Slide 18, we are highlighting overall survival results shared at ESMO earlier this month from Arm A1 of the Phase II EDGE-Gastric study, evaluating domvanalimab, o”