What's Happening?
Gilead Sciences has released new data from its Phase 3 ASCENT-03 trial, indicating that its cancer drug Trodelvy, when combined with chemotherapy, significantly reduces the risk of disease progression
or death in patients with metastatic triple-negative breast cancer (TNBC). The trial results showed a 38% reduction in progression risk compared to chemotherapy alone. Patients treated with Trodelvy had a median progression-free survival of nearly 10 months, compared to 7 months for those on standard chemotherapy. The study, led by Javier Cortes at the International Breast Cancer Center in Spain, suggests Trodelvy could become a new standard of care for TNBC patients who are ineligible for immunotherapy.
Why It's Important?
The findings from this trial represent a potential breakthrough for patients with TNBC, a particularly aggressive form of breast cancer with limited treatment options. Trodelvy's ability to extend progression-free survival offers a significant advancement in care for these patients. The drug's manageable safety profile further supports its potential as a first-line treatment. Gilead's ongoing discussions with the FDA and global regulators about expanding Trodelvy's approval could lead to broader access and improved outcomes for patients worldwide. The positive trial results have also fueled investor interest, with Gilead's stock rising 36% in 2025.
What's Next?
Gilead is in talks with the FDA and other global regulators to expand Trodelvy's approval for earlier-stage use. The company is also exploring the drug's efficacy in other cancers, including lung and gynecologic cancers, as part of its strategy to establish Trodelvy as a cornerstone of its oncology portfolio. These efforts could lead to wider adoption of Trodelvy in clinical practice, offering new hope to patients with various types of cancer.
