CLAIM #27186 · GILD (GILD) · 2024Q4 earnings call · Feb 11, 2025 · due Dec 31, 2026
“These trials could provide Trodelvy the opportunity to advance into the first line setting for metastatic triple negative breast cancer as early as 2026.”
Dietmar Berger · CMO
How to check this claim
Look at: FDA regulatory approval status of Trodelvy for first-line metastatic triple-negative breast cancer
It came true if: FDA approves Trodelvy label expansion to first-line metastatic triple-negative breast cancer setting on or before 2026-12-31
Where: Company press releases / FDA.gov drug approval database / Gilead 10-K or 10-Q regulatory updates
In context
“with the hopes of demonstrating seladelpar's capacity to normalize biochemical markers of disease activity in this previously understudied patient population with incomplete control of ALP levels. Moving to oncology on Slide 22. We remain focused on clinical execution of our eight ongoing Phase 3 programs for Trodelvy and domvanalimab across five tumor types. This year, we anticipate providing updates from the Phase 3 ASCENT-03 trial evaluating Trodelvy in first line metastatic triple negative breast cancer patients who are not candidates for anti-PD-1 therapy in the first half of 2025 and from the Phase 3 ASCENT-04 trial evaluating Trodelvy in combination with Merck's pembrolizumab in first-line PD-L1 positive metastatic triple-negative breast cancer patients in the second half of 2025. These trials could provide Trodelvy the opportunity to advance into the first line setting for metastatic triple negative breast cancer as early as 2026. Additionally, we have the Phase 3 ASCENT-07 trial in chemotherapy naive hormone receptor-positive, HER2 negative metastatic breast cancer that completed enrollment in August of last year. In lung cancer, Trodelvy continues to be evaluated in combination with pembro in first line PD-L1 high metastatic non-small cell lung cancer in the Phase 3 EVOKE-03 study. Further, FDA has granted Trodelvy breakthrough therapy designation for extensive stage small cell lung cancer patients whose disease progressed on or after platinum based chemotherapy. Unfortunately, most small cell lung cancer cases are diagnosed in extensive stage, given the aggressive nature of the disease, and median overall survival typically is between 8 and 12 months. In the small cell lung cancer cohort of the Phase 2 TROPiCS-0”
Verify independently
SEC filings for GILD ↗ · Claim quote is verbatim from the 2024Q4 earnings call.