- Gilead Sciences Inc 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.
- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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