Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the confirmatory Phase 3 TROPiCS-04 study in locally advanced or metastatic urothelial cancer (mUC). The TROPiCS-04 study evaluated Trodelvy® (sacituzumab govitecan-hziy; SG) vs. single-agent chemotherapy (treatment of physicians’ choice, TPC) 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 (OS) in the intention-to-treat (ITT) 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 (PFS) and overall response rate (ORR) 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 (G-CSF) 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.
Gilead is continuing to analyze the data and will discuss the results and next steps with the FDA. In the U.S., Trodelvy has an accelerated approval indication for patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and anti-PD-(L)1 therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials, including the TROPiCS-04 study.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.