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.