May 30 (Reuters) - Gilead Sciences ( GILD ) said on
Thursday its drug Trodelvy, tested in patients with bladder
cancer who previously received chemotherapy and other
anti-cancer therapies, did not meet the main goal of a
late-stage study.
The company said the drug did not meet the main goal of
overall survival.
In the overall study population, there was a higher
number of deaths due to adverse events with Trodelvy, which
belongs to a class of treatments known as antibody-drug
conjugates, compared to chemotherapy, Gilead said.
The deaths were primarily observed early in treatment
and related to neutropenic complications - that involve
lower-than-normal levels of a type of white blood cell -
including infection.
"There are no changes to the known safety profile of
Trodelvy for the approved breast cancer indications or other
investigational uses," the company said.
The drugmaker is continuing to analyze the data and will
discuss the results and next steps with the U.S. Food and Drug
Administration, it said.
Continued approval for this indication may be contingent
upon verification of clinical benefit in confirmatory trials,
including this late-stage trial, the California-based company
said.
The study tested the drug versus chemotherapy in
patients with metastatic urothelial cancer or bladder cancer.