Key takeaways
Trodelvy achieves primary endpoint in first-line mTNBC: The ASCENT-03 Phase III trial demonstrated a statistically significant and clinically meaningful improvement in PFS for Trodelvy versus physician’s choice of chemotherapy in first-line metastatic triple-negative breast cancer—a key development for future protocol design and trial strategy in this population.
Study design reflects real-world treatment scenarios: The open-label, randomized design with physician’s choice comparator arms (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) reflects practical flexibility in clinical settings, enhancing applicability of trial results and easing operational execution.
Safety profile consistency supports operational scalability: The consistency of Trodelvy’s safety profile across studies, including ASCENT-03, simplifies site training, monitoring plans, and patient management protocols—reducing operational complexity for future trials involving this agent.
Gilead has shared positive results from the Phase III ASCENT-03 clinical trial of Trodelvy (sacituzumab govitecan-hziy). In patients with first-line metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1/PD-L1 inhibitors, the study showed that Trodelvy achieved a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy, meeting the primary endpoint.1
In a press release, Javier Cortes, MD, PhD, head of the International Breast Cancer Center in Spain and principal investigator of the ASCENT-03 study, said: “Almost half of the patients diagnosed with metastatic triple-negative breast cancer do not receive treatment beyond first-line, demonstrating an urgent need for innovative treatment options in this early setting. Traditional chemotherapy has been the standard of care for early treatment of metastatic triple-negative breast cancer, and we know that therapeutic advances in this disease area serve a critical unmet need for patients and the broader oncology community.”
ASCENT-03 trial design and treatment comparison
ASCENT-03 (NCT05382299) is a global, open-label, randomized trial. Its primary objective was to compare PFS between Trodelvy and the treatment of physician's choice in mTNBC patients. The study randomized 540 participants 1:1 to receive Trodelvy at 10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle, or the treatment of physician’s choice, which included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel.2
Key secondary endpoints include OS, ORR, and patient-reported outcomes
In addition to the primary endpoint of PFS, the study included key secondary endpoints of overall survival (OS), objective response rate (ORR), duration of response (DoR), time to onset of response, patient-reported outcomes, and safety.
In the press release, Dietmar Berger, MD, PhD, chief medical officer, Gilead Sciences, added: “The ASCENT-03 outcome represents the first clinically meaningful advance for this patient population in over 20 years versus chemotherapy. By addressing this aggressive and difficult to treat disease earlier, we can potentially improve treatment options for the high unmet need that patients with metastatic triple-negative breast cancer face.”
