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Gilead's Breast Cancer Drug Improves Progression-Free Survival in HR+/HER2- Metastatic Breast Cancer

·1 min read
  • Gilead Sciences Inc (NASDAQ: GILDoutlined new data for the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) ahead of their presentation at the European Society of Medical Oncology.

  • The results come from a post hoc subgroup analysis from the Phase III TROPiCS-02 study, which examines the impact of the therapy in the later-line treatment of breast cancer.

  • Progression-free survival (PFS) analysis showed that Trodelvy improved median PFS compared to the prescriber’s choice of chemo in heavily pretreated patients with locally recurrent inoperable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer.

  • Related: After Surprise Overall Survival Data In Metastatic Breast Cancer, Gilead Takes Complete Rights To Trodelvy.

  • Findings showed that the median PFS of patients with HER2-low breast cancer in the sacituzumab govitecan arm was 6.4 months vs. 4.2 months in the standard of care arm.

  • While the overall survival (OS) data were not mature, investigators noted a numeric trend toward improvement with the antibody-drug conjugate vs. standard care.

  • No new toxicity signals were observed with sacituzumab govitecan, and those shown were manageable based on observations in prior studies.

  • Sacituzumab govitecan is currently not approved by any regulatory agency for HR+/HER2- metastatic breast cancer as its safety and efficacy have not been established for this indication.

  • However, a supplemental biologics license application has been submitted to the FDA based on data from TROPiCS-02.

  • Price Action: GILD shares are down 0.56% at $63.47 on the last check Tuesday.

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