RTTNews | Dec 10, 2021 09:14AM EST

09:14 Friday, December 10, 2021 (RTTNews.com) - Biopharmaceutical company Gilead Sciences, Inc. (GILD) on Friday announced results of a Phase 3 study that showed clinical benefit for Trodelvy (sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) in patients who received two or more prior systemic therapies, at least one of them for metastatic disease.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein overexpressed in multiple types of epithelial tumors, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse.

The study dubbed ASCENT that enrolled more than 500 patients across 230 study locations, conducted on a subgroup of Black patients, revealed improved progression-free survival (PFS), with a 56 percent reduction in the risk of disease worsening or death. The median PFS was at 5.4 months versus 2.2 months with chemotherapy. Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician's choice of chemotherapy.

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 results were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS).

The study assumes significance as black women are seen more likely to be diagnosed with TNBC and may experience worse clinical outcomes compared with white women due to comorbidities, differences in TNBC biology and other health disparities. The 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 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.

Trodelvy is approved for adults with metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland. Trodelvy is also under multiple regulatory reviews worldwide, including in Singapore and China.

Shares of Gilead Sciences are trading in pre-market at $70.22. down $ 0.08 or 0.11 percent from previous close.

Read the original article on RTTNews ( https://www.rttnews.com/3248516/trodelvy-shows-clinical-benefit-for-black-patients-in-full-metastatic-triple-negative-breast-cancer.aspx)

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