Trodelvy Significantly Improved Quality of Life Over Standard of Care in 2L+ Metastatic Triple-Negative Breast Cancer in Phase 3 ASCENT Study - Seite 2

“Many metastatic TNBC patients’ disease will quickly progress following chemotherapy, so the survival benefit with Trodelvy is highly meaningful, and the quality of that time is also very important,” said Bill Grossman, MD, PhD, Senior Vice President, Oncology Clinical Research, Gilead Sciences. “We are committed to improving overall outcomes for patients with this aggressive disease, including more and potentially better time when it matters most.”

The safety profile of Trodelvy was consistent with prior reports from the ASCENT study. 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.

About Triple-Negative Breast Cancer

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.

About the ASCENT Study

The ASCENT study is a global, open-label, randomized phase 3 study that enrolled more than 500 patients across 230 study locations. The study evaluated the efficacy and safety of Trodelvy compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior systemic treatments. Patients were randomized to receive either Trodelvy or a chemotherapy chosen by the patients’ treating physicians. The primary endpoint was PFS (as determined by blinded independent central review) in patients without brain metastases. Secondary endpoints included: PFS for full study population or intention-to-treat (ITT) population, overall survival in both the ITT population and in the subgroup without brain metastasis, independently determined objective response rate, duration of response, time to onset of response according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), quality of life and safety. More information about ASCENT is available at http://clinicaltrials.gov/show/NCT02574455.