FOSTER CITY (dpa-AFX) - 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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