Gilead Sciences Inc (NASDAQ: GILD) outlined 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.
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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