Gilead Sciences has reported that its Phase III TROPiCS-04 clinical trial of Trodelvy in patients with locally advanced or metastatic urothelial cancer (mUC) did not meet its primary endpoint of overall survival (OS).
The global, open-label, multi-centre, randomised trial involved 711 patients who were previously treated with platinum-containing chemotherapy and checkpoint inhibitor therapy.
They were randomised to receive either Trodelvy or the physician’s choice of single-agent chemotherapy of either paclitaxel, docetaxel, or vinflunine.
The trial's secondary endpoints included progression-free survival, objective response rate, clinical benefit rate, and duration of objective tumour response.
Despite not achieving the primary endpoint in the intention-to-treat population, a numerical improvement in OS favouring Trodelvy was observed.
The study also indicated trends towards better outcomes in progression-free survival and overall response rates in certain pre-specified subgroups. However, these subgroup analyses were not statistically controlled for formal testing.
In the overall trial population, an increased number of mortality cases due to adverse events was seen with Trodelvy versus TPC, which were mainly seen early in the treatment stage and linked to neutropenic complications, including infection.
The safety profile of Trodelvy was found to be well-tolerated and in line with those seen in over 40,000 patients across approved indications of Trodelvy and trials.
Gilead plans to assess the trial data further and will consult with the Food and Drug Administration (FDA) regarding future steps.
Trodelvy is currently approved for use in the US under an accelerated pathway for locally advanced or metastatic urothelial cancer priorly treated with platinum-containing chemotherapy and anti-PD-(L)1 therapy.
Gilead has more than 20 ongoing clinical trials investigating Trodelvy across various indications.
In February 2023, the company reported updated positive data from three cohorts of the Phase II TROPHY-U-01 trial of Trodelvy in mUC patients.
