Gilead Sciences' Trodelvy Study In Breast Cancer Meets Primary Endpoint

  • Gilead Sciences Inc GILD announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer.
  • The trial included breast cancer patients who received prior endocrine therapy, CDK4/6 inhibitors, and two to four lines of chemotherapy. 
  • The study met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician's choice of chemotherapy. 
  • But at the interim analysis, analysts and observers were left questioning just how significant the benefit was, as Gilead did not release any hard data.
  • The trial targeted a 30% reduction in disease progression or death risk. 
  • The first interim analysis of the key secondary endpoint of overall survival in the TROPiCS-02 study demonstrated a trend in improvement for overall survival. 
  • Patients will be followed for subsequent overall survival analysis. The safety profile for Trodelvy was consistent with prior studies, and no new safety concerns emerged in this patient population.
  • Much of the consternation stems from a Q&A in an 8-K report Gilead filed with the SEC attempting and failing to assuage concerns. 
  • Price Action: GILD shares are down 0.91% at $61.30 during the market session on the last check Monday.
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Posted In: BiotechNewsHealth CareGeneralbreast cancerBriefsPhase 3 Trial
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