Gilead Sciences’ drug Trodelvy, when used in combination with Merck’s immunotherapy Keytruda, significantly improved outcomes in patients with advanced triple-negative breast cancer (TNBC). Data from a large Phase 3 trial presented at the American Society of Clinical Oncology (ASCO) showed that this combination reduced the risk of disease progression by 35% compared to standard treatments. Experts believe these results are substantial enough to potentially reshape the standard of care for newly diagnosed patients with this aggressive form of breast cancer.
Trodelvy-Keytruda Combo Extends Survival, May Become New Standard for TNBC Treatment
The trial followed 443 patients over a median period of 14 months. Those receiving the Trodelvy-Keytruda combination had a progression-free survival (PFS) of 11.2 months, compared to 7.8 months in the group treated with chemotherapy and Keytruda. Additionally, the median duration of response was 16.5 months for the Trodelvy group versus 9.2 months for the chemotherapy group. Patients continue to be monitored to determine whether the treatment also improves overall survival rates.

Dr. Jane Lowe Meisel, a breast oncology expert at Emory University and ASCO representative, remarked that this regimen will likely become the new front-line standard for eligible TNBC patients. Approximately 10% of breast cancers in the U.S. are triple-negative, a subtype that lacks the common biomarkers that guide treatment in other breast cancers, making it more difficult to manage. Notably, 40% of these TNBC cases are PD-L1 positive, making them suitable for Keytruda-based therapies.
Targeted Treatment with Manageable Side Effects Shows Promise for Advanced Breast Cancer Cases
Trodelvy is an antibody-drug conjugate, meaning it targets cancer cells more precisely, aiming to limit damage to healthy cells compared to traditional chemotherapy. However, the treatment is not without side effects. In the Trodelvy-Keytruda group, 43% of patients experienced neutropenia, a condition involving low white blood cell counts, while 10% experienced diarrhea. These rates were comparable to or slightly better than those in the chemotherapy group, where 45% experienced neutropenia, 16% anemia, and 14% low platelet counts.
Trodelvy is already approved for use in patients with advanced TNBC who have undergone two or more prior therapies, as well as for hormone-receptor-positive, HER2-negative breast cancers. Gilead is expanding research into Trodelvy’s use, including studies targeting patients whose TNBC tumors do not express PD-L1. These efforts indicate a growing role for precision oncology in treating one of the most aggressive breast cancer subtypes.