libre de droit A phase 3 study examining Gilead Sciences' ( NASDAQ: GILD ) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival for urothelial cancer, the most common type of bladder cancer, in the intention-to-treat population. There were trends in improvement for some pre-specified subgroups and secondary endpoints of progression-free survival and overall response rate were met. The TROPiCS-04 study examined Trodelvy vs.
single-agent chemotherapy in patients with urothelial cancer who have previously received platinum-containing chemotherapy and anti-PD-( L )1 therapy. Gilead also noted that there were more deaths from adverse events in the Trodelvy cohort compared to the chemo group, those they were seen mostly early in treatment and related to neutropenia. The results could be problematic for the biotech given that the antibody-drug conjugate received U.
S. FDA accelerated approval for urothelial cancer in 2021. It was approved based on tumor response rate and duration of response.
When accelerated approval is granted, drugmakers need to conduct post-marketing studies to confirm a therapy's efficacy. Gilead ( GILD ) shares are down ~3% in after-hours trading Thursday. More on Gilead Sciences Gilead Sciences: Seriously Undervalued At Peak Pessimism Gilead Sciences: Disappointing Fundamentals And Sentiment, But Still Bullish Unloved Gilead Due For Reversal On Flight-To-Safety Money Flows Gilead partnering with Cartography Biosciences to disc.