Gilead’s Trodelvy fails to meet main goal in late-stage cancer study
London: Gilead Sciences 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.
Shares of Gilead fell 3.3 per cent in extended trade after 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 analyse 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.
(Reporting by Sneha S K; Editing by Alan Barona)
Source – ETHealth World
