US biotech major Gilead Sciences (Nasdaq: GILD) has announced positive results from the primary analysis of the Phase III TROPiCS-02 study of Trodelvy (sacituzumab govitecan-hziy) versus physicians’ choice of chemotherapy (TPC) in heavily pre-treated HR+/HER2- metastatic breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.
The study met its primary endpoint of progression-free survival (PFS) with a statistically significant and clinically meaningful 34% reduction in the risk of disease progression or death (median PFS 5.5 versus 4 months; HR: 0.66; 95% CI: 0.53-0.83; P<0.0003). The first interim analysis of the key secondary endpoint of overall survival (OS) demonstrated a trend in improvement. These data are immature, and patients will be followed for subsequent OS analysis.
The findings were featured in both a press briefing and an oral session on Saturday, June 4, during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.
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