LOGO
LOGO

Quick Facts

Gilead : Phase 3 Study Of Trodelvy In Metastatic Urothelial Cancer Fails To Meet Primary Endpoint

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Gilead Sciences Inc. (GILD) said that the confirmatory Phase 3 TROPiCS-04 study of Trodelvy in locally advanced or metastatic urothelial cancer did not meet the primary endpoint of overall survival.

GILD closed Thursday's regular trading at $64.08 up $0.58 or 0.91%. But in the after-hours trading, the stock dropped $2.08 or 3.25%.

The TROPiCS-04 study evaluated Trodelvy (sacituzumab govitecan-hziy; SG) compared to single-agent chemotherapy (treatment of physicians' choice, TPC) in patients with metastatic urothelial cancer or mUC who have previously received platinum-containing chemotherapy and anti-PD-(L) therapy.

In the study, a numerical improvement in overall survival favoring Trodelvy was observed, and trends in improvement for select pre-specified subgroups and secondary endpoints of progression-free survival and overall response rate were also shown, the company said.

The pre-specified subgroup analyses were not alpha-controlled for formal statistical testing.

In the overall study population, there was a higher number of deaths due to adverse events with Trodelvy compared to TPC, which were primarily observed early in treatment and related to neutropenic complications, including infection. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia.

However, the company said there are no changes to the known safety profile of Trodelvy for the approved breast cancer indications or other investigational uses.

For More Such Health News, visit rttnews.com.

For comments and feedback contact: editorial@rttnews.com

Business News

Global Economics Weekly Update - Jun 01 - Jun 05, 2026

June 05, 2026 16:18 ET
A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.

Latest Updates on COVID-19