Gilead’s Trodelvy Doubles Overall Survival in Specific TNBC Patients, Demonstrates Positive Phase 3 Results at ASCO

On June 5, Gilead Sciences, Inc. presented updated results from the Phase 3 clinical trial of its "first-in-class" antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) for the treatment of patients with relapsed or refractory triple-negative breast cancer (TNBC) at the ASCO Annual Meeting. In a subgroup of metastatic patients who had previously received only one prior systemic therapy, Trodelvy reduced the risk of disease progression or death by 59% (HR: 0.41; 95% CI: 0.22-0.76). The median progression-free survival (PFS) was 5.7 months for patients treated with Trodelvy, compared with 1.5 months in the chemotherapy group.

Trodelvy also extended overall survival to 10.9 months, compared with 4.9 months in the chemotherapy group (HR: 0.51; 95% CI: 0.28–0.91). Furthermore, Trodelvy demonstrated a higher overall response rate compared with chemotherapy (30% vs. 3%). Regarding safety, the profile in this patient subgroup was consistent with previous reports.

Notably, Everest Medicines holds the development rights for this innovative antibody-drug conjugate (ADC) in the Greater China region. It has been approved in China to conduct Phase III clinical trials for the treatment of metastatic triple-negative breast cancer and advanced urothelial carcinoma in patients who have received at least two prior lines of therapy.

TNBC is an aggressive form of breast cancer that accounts for approximately 15% of all breast cancer cases. It is more common in young and premenopausal women. Triple-negative refers to tumors that are negative for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). Treatment options for these patients are limited.

Trodelvy is a "first-in-class" antibody-drug conjugate developed by conjugating a topoisomerase inhibitor to a monoclonal antibody targeting the Trop-2 receptor. The Trop-2 receptor is frequently expressed in various human epithelial cancers, and its high expression is associated with a poor prognosis in metastatic triple-negative breast cancer and urothelial carcinoma.

“Given the rapid disease progression many patients experience following chemotherapy, the efficacy results of Trodelvy as a second-line therapy for metastatic patients are highly significant. We are pleased to see that it doubles the median overall survival for patients,” said Dr. Daejin Abidoye, Head of Oncology Clinical Development at Gilead Sciences.

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