Gilead's Trodelvy Shows Improved Overall Survival In Pretreated Breast Cancer Settings

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  • Gilead Sciences Inc GILD announced the overall survival (OS) results from the Phase 3 TROPiCS-02 study of Trodelvy (sacituzumab govitecan-hziy) versus comparator chemotherapy (TPC) in HR+/HER2- metastatic breast cancer patients who received endocrine-based therapies and at least two chemotherapies. 
  • The TROPiCS-02 study met its primary endpoint of progression-free survival earlier this year.
  • Related: Gilead's Breast Cancer Drug Improves Progression-Free Survival in HR+/HER2- Metastatic Breast Cancer.
  • Trodelvy demonstrated a statistically significant and clinically meaningful improvement of 3.2 months in OS compared to chemo (median OS: 14.4 months vs. 11.2 months).
  • Other secondary endpoints, including objective response rate (ORR), demonstrated statistically significant improvement in favoring Trodelvy versus the physician's choice of chemo TPC. 
  • Time to deterioration (TTD) also favored Trodelvy versus TPC (with a quality of life score of 4.3 months vs. 3.0 months) and a Fatigue score of 2.2 months vs. 1.4 months. No statistically significant difference in TTD on the Pain Scale was observed.
  • The safety profile for Trodelvy was consistent with prior studies, with no new safety signals identified.
  • Price Action: GILD shares are up 0.73% at $65.26 on the last check Thursday.
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