Gilead Trodelvy shows benefit in breast cancer patients regardless of HER2 mutation in trial
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Gilead Sciences (NASDAQ:GILD) said Trodelvy showed progression-free survival (PFS) benefit in patients with breast cancer patients regardless of the HER2 mutation status.
The company reported data from a post hoc subgroup analysis from a phase 3 trial, dubbed TROPiCS-02, which evaluated Trodelvy (sacituzumab govitecan-hziy) against comparator chemotherapies (physicians' choice of chemotherapy, TPC) in patients with HR+/HER2- metastatic breast cancer who progressed on endocrine-based therapies and at least two chemotherapies.
The analysis tested PFS â length of time during/after treatment that a patient lives without the disease getting worse â in the intention-to-treat population by HER2-immunohistochemistry (IHC) status, and data showed that Trodelvy improved median PFS vs. TPC in both HER2-low (IHC1+ and IHC2+/ISH-negative) and IHC0 groups, the company said in a Sept. 5 press release.
Gilead added that detailed findings will be presented at a mini-oral session during the European Society for Medical Oncology (ESMO) Congress 2022 on Sept. 10.
"Trodelvy is already transforming the standard of care in second-line metastatic triple-negative breast cancer, and weâre excited about its potential in other breast cancers where there is significant need for new treatment options," said Bill Grossman, senior vice president, Therapeutic Area Head, Gilead Oncology.
The company noted that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) based on data from TROPiCS-02.