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

(RTTNews) - 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.

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