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Gilead's Trodelvy Misses Main Goal In Breast Cancer Study But Shows Early Survival Trend

Author: Vandana Singh | November 07, 2025 10:10am

Gilead Sciences Inc. (NASDAQ:GILD) announced on Friday data from the Phase 3 ASCENT-07 study of Trodelvy (sacituzumab govitecan-hziy) versus chemotherapy in HR+/HER2-negative metastatic breast cancer patients.

The trial included patients who received prior endocrine therapy and were candidates for cytotoxic chemotherapy.

The study did not meet the primary endpoint of progression-free survival (PFS), the time during and after treatment when a disease, such as cancer, does not get worse.

Overall survival is a key secondary endpoint and was not mature at the time of the primary analysis; however, an early trend favoring Trodelvy over chemotherapy was observed.

The ASCENT-07 study will continue to further assess overall survival.

Also Read: Gilead’s HIV Drugs Power Earnings Beat, Company Eyes Multiple Launches By 2026

The safety profile was consistent with prior Trodelvy breast cancer studies, and no new safety signals were identified in this patient population.

On Friday, Gilead shared new long-term data for Livdelzi (seladelpar) for people living with primary biliary cholangitis (PBC). In this autoimmune liver disease, the small bile ducts are slowly destroyed, leading to a buildup of bile in the liver (cholestasis).

Findings support Livdelzi’s consistent efficacy and safety outcomes in patients switching from obeticholic acid and a positive impact on liver stiffness over 3 years.

These findings were presented at The Liver Meeting hosted by the American Association for the Study of Liver Diseases 2025.

New interim results from the open-label Phase 3 ASSURE trial show that 67% of participants achieved a composite biochemical response. In comparison, 34% reached normalized ALP enzyme levels after three years of treatment with Livdelzi.

New data from the pivotal RESPONSE study and its open-label extension, ASSURE, show that Livdelzi delivers a sustained and meaningful reduction in chronic itch.

Price Action: GILD stock is down 0.36% at $122.95 at the last check on Friday.

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Posted In: GILD

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