Gilead says Phase 3 TROPiCS-04 study did not meet primary endpoint

Gilead Sciences announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer. The TROPiCS-04 study evaluated Trodelvy vs. single-agent chemotherapy in patients with mUC who have previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy. The study did not meet the primary endpoint of overall survival in the intention-to-treat population. A numerical improvement in OS 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 pre-specified subgroup analyses were not alpha-controlled for formal statistical testing. These data will be presented at an upcoming medical meeting. 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. Gilead will further investigate these data, and is working to reiterate to treating physicians the importance of granulocyte-colony stimulating factor use for the prevention of neutropenic complications. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia; please see below for Important Safety Information. There are no changes to the known safety profile of Trodelvy for the approved breast cancer indications or other investigational uses. To date, the Trodelvy safety profile is generally well-tolerated and consistent with use in over 40,000 patients across Trodelvy’s approved indications and in clinical trials.