Trodelvy Shows Promise in Treating Metastatic Triple-Negative Breast Cancer by Reducing Risks

Promising Results from the ASCENT-03 Trial

Introduction

On October 19, Gilead Sciences, headquartered in Foster City, California, shared the encouraging results of its ASCENT-03 trial at the European Society for Medical Oncology (ESMO) 2025 and in the New England Journal of Medicine. This clinical trial assessed Trodelvy (sacituzumab govitecan) in comparison to traditional chemotherapy for patients with metastatic or recurrent triple-negative breast cancer (TNBC) who are not eligible for PD-1/PD-L1 inhibitors.

Study Overview

The ASCENT-03 trial showcased significant improvements in progression-free survival (PFS), demonstrating a 38% reduction in the risk of disease progression or death. The primary endpoint was achieved with Trodelvy displaying a median PFS of 9.7 months, significantly better than the 6.9 months seen in the chemotherapy group (Hazard Ratio: 0.62; p<0.0001).

Dr. Javier Cortés, the principal investigator at the International Breast Cancer Center in Spain, pointed out the essential advancement Trodelvy provides for a patient population that often faces a bleak prognosis and has limited treatment options. He emphasized that the medication's ability to extend survival rates can represent a landmark moment in TNBC treatment.

Effectiveness of Trodelvy

The efficacy results of ASCENT-03 are promising, with the objective response rate (ORR) for Trodelvy-treated patients at 48%, slightly higher than the chemotherapy group at 46%. Moreover, the duration of response (DOR) was notably extended in the Trodelvy cohort, who presented DOR at 12.2 months compared to the 7.2 months observed in the chemotherapy group.

Ongoing Monitoring and Future Implications

While overall survival (OS) data is still maturing, Gilead will continue to track these patients for comprehensive analyses and future evaluations of OS outcomes. The findings from the ASCENT-03 trial complement the recent ASCENT-04/KEYNOTE-D19 trial results, which indicated that Trodelvy combined with Keytruda (pembrolizumab) shows notable PFS improvement for patients with PD-L1 positive TNBC.

Dr. Dietmar Berger, Gilead’s Chief Medical Officer, added that ASCENT-03 is the second phase III trial demonstrating the superiority of Trodelvy in the first-line treatment of metastatic and recurrent TNBC compared to chemotherapy, shedding light on the possibility of improved patient outcomes.

Patient Safety Profile

The safety profile of Trodelvy aligns with findings from previous trials, with no new safety signals identified in the studied population. Notably, the occurrence of grade 3 or higher adverse events was comparable between both groups, with neutropenia and diarrhea emerging as the most common adverse effects. Importantly, fewer patients in the Trodelvy group discontinued treatment due to adverse events compared to the chemotherapy group (4% vs. 12%).

Current Use of Trodelvy

Trodelvy has gained acceptance among healthcare professionals and has been administered to over 60,000 patients in more than 50 countries over the past five years. It is the only antibody-drug conjugate targeting TROP-2 that has demonstrated significant survival benefits for metastatic TNBC and previously treated hormone receptor-positive, HER2-negative breast cancer.

Conclusion

Frustratingly, treatment options remain limited for TNBC patients not suitable for immune therapy, emphasizing the urgent need for effective early treatment alternatives. Many patients still lack follow-up treatments following first-line therapy. The ASCENT-03 trial represents a crucial step towards providing meaningful advancements in the treatment landscape for this challenging condition, potentially redefining the standard of care for TNBC patients.