CLAIM #27322 · GILD (GILD) · 2025Q3 earnings call · Oct 30, 2025 · due Dec 31, 2025
“We now expect to provide an update from this trial before the end of the year.”
Dietmar Berger · Chief Medical Officer
In context
“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, our Fc-silent anti-TIGIT plus zimberelimab and chemotherapy in patients with locally advanced unresectable or metastatic upper gastrointestinal cancers. In the 41 patients who received a novel regimen in this analysis, the median overall survival was 26.7 months. These findings were simultaneously published in Nature Medicine. These data are in a small number of patients. Survival results for this patient population still need to be confirmed in our ongoing Phase III STAR-221 trial evaluating domvanalimab plus zimberelimab and chemotherapy in patients with metastatic upper gastrointestinal cancers. We continue to expect an upd”
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SEC filings for GILD ↗ · Claim quote is verbatim from the 2025Q3 earnings call.