FOSTER CITY, Calif.– Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the Phase 3 ASCENT study evaluating Trodelvy® (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In this subgroup analysis of Black patients, Trodelvy improved progression-free survival (PFS), with a 56% reduction in the risk of disease worsening or death (HR: 0.44; 95% CI: 0.24-0.80; P=0.008) and a median PFS of 5.4 months (n=28) versus 2.2 months with chemotherapy (n=34). Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician’s choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). The results were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Poster #P5-16-07).
“Black women are almost three times more likely to be diagnosed with TNBC and may experience worse clinical outcomes compared with white women,” said Lisa Carey, MD, Medical Director of the UNC Breast Center, the Physician-in-Chief of the North Carolina Cancer Hospital and Associate Director of Clinical Research at UNC Lineberger Comprehensive Cancer Center. “This inequality is driven by comorbidities, differences in TNBC biology and other health disparities, which is why understanding how sacituzumab govitecan can work in these patients is so critical. This analysis of the Phase 3 ASCENT study confirms that sacituzumab govitecan delivered the same clinical benefit for Black women as the overall population in second-line locally advanced or metastatic TNBC.”
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. Black women have three times the risk of TNBC as white women, and a 42% higher mortality rate from breast cancer overall. The five-year survival rate for this sub-type of breast cancer is 12%, compared with 28% for other breast cancer types, and these poor outcomes are often coupled with a significant decrease in quality of life, especially in relapsed/refractory disease.
Additionally, Trodelvy demonstrated a higher overall response rate (32% versus 6%) and clinical benefit rate (43% versus 15%) compared with physician’s choice of chemotherapy in this subgroup. Efficacy and safety results from this subgroup were consistent with those observed in the overall ASCENT study population.
The most frequent Grade ≥3 treatment-related adverse reactions for Trodelvy compared to chemotherapy were neutropenia (48% versus 42%), anemia (12% versus 6%), leukopenia (8% versus 16%), and febrile neutropenia (8% versus 3%). In this subgroup, no patients in the Trodelvy arm and one patient in the chemotherapy arm discontinued treatment due to adverse reactions. There were no treatment-related deaths with Trodelvy in this subgroup. The Trodelvy U.S. Prescribing Information has a BOXED WARNING for severe or life-threatening neutropenia and severe diarrhea; see below for Important Safety Information.
“Black women with TNBC have historically faced a poorer prognosis compared to white women,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. “Gilead is committed to the continued advancement of transformational science for those impacted by cancer, and we are pleased this analysis affirms consistent clinical outcomes with Trodelvy for Black women in second-line metastatic TNBC.”
