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# Gilead’s Mixed Data on Trodelvy in Metastatic Breast Cancer
- URL: https://www.fdaweb.com/gileads-mixed-data-on-trodelvy-in-metastatic-breast-cancer/
- Published: 2022-03-07T12:00:00.000Z
- Updated: 2026-09-14T17:35:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151302

Gilead Sciences says results from its Phase 3 TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2-metastatic breast cancer showed that the therapy met its primary endpoint with a statistically significant improvement in progression-free survival (PFS) versus physician’s choice of chemotherapy. Patients on the study drug received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy.

Gilead says the trial targeted a 30% reduction in the risk of disease progression or death. “The primary endpoint results were consistent with those observed in the Phase 1/2 IMMU-132-01 study in a subset of HR+/HER2-metastatic breast cancer patients” it says. “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,” which the company says “means Trodelvy is showing a numerical improvement that was not statistically significant at the first interim analysis.” Patients will be followed while the “data matures” for a final overall survival analysis. 

In a [financial filing](https://investors.gilead.com/node/39551/html?ref=fdaweb.com), the company addressed whether the PFS finding met its bar for being clinically meaningful. “There is a broad range of views on what is ‘clinically meaningful’ in this population,” it said, adding that it is still evaluating the data and will explore potential pathways with regulatory authorities.

Trodelvy is currently approved for treating certain adult patients with unresectable locally advanced or metastatic triple-negative breast cancer, and certain adult patients with locally advanced or metastatic urothelial cancer.