What's Happening?
Gilead Sciences, Inc. has announced positive results from the Phase 3 ASCENT-03 study, demonstrating that Trodelvy® (sacituzumab govitecan-hziy) significantly improves progression-free survival (PFS) in patients with metastatic triple-negative breast
cancer (TNBC) compared to chemotherapy. The study, presented at the 2025 European Society for Medical Oncology Congress, showed a 38% reduced risk of disease progression or death with Trodelvy. The median PFS was 9.7 months for Trodelvy versus 6.9 months for chemotherapy. These findings suggest Trodelvy could become a new standard of care for first-line metastatic TNBC patients who are not candidates for PD-1/PD-L1 inhibitors.
Why It's Important?
The ASCENT-03 study marks a significant advancement in the treatment of metastatic TNBC, a particularly aggressive form of breast cancer with limited treatment options. The ability of Trodelvy to delay disease progression offers hope for patients who face a poor prognosis. This development could transform the treatment landscape for TNBC, providing a much-needed alternative to chemotherapy and potentially improving survival rates. The study's results may influence clinical practice and regulatory approvals, impacting patient care and treatment protocols.
What's Next?
Gilead Sciences plans to continue monitoring overall survival outcomes and engage with regulatory bodies, including the U.S. Food and Drug Administration, regarding the study's findings. Further analysis and ongoing patient follow-up are expected to provide additional insights into the long-term benefits of Trodelvy. The company is also exploring the use of Trodelvy in combination with other therapies, which could further enhance treatment efficacy for TNBC patients.
