Gilead’s Trodelvy Fails to Meet Primary Endpoint in Confirmatory Trial for Urothelial Cancer

1. Gilead's TROPiCS-04 study fails to meet primary endpoint: The study evaluating Trodelvy in locally advanced or metastatic urothelial cancer did not achieve its primary endpoint of overall survival (OS) in the intention-to-treat (ITT) population.
2. Higher deaths due to adverse events: The study reported a higher number of deaths due to adverse events with Trodelvy compared to single-agent chemotherapy, primarily related to neutropenic complications.
3. Improvements in select subgroups and secondary endpoints: Despite the primary endpoint miss, the study showed improvements in progression-free survival and overall response rate in certain subgroups and secondary endpoints.
4. Impact on FDA approval: The accelerated approval of Trodelvy for urothelial cancer is contingent on the verification and description of clinical benefits in confirmatory trials, including TROPiCS-04. The study's failure to meet its primary endpoint may jeopardize this approval.
5. Gilead's oncology franchise: Trodelvy is a key part of Gilead's oncology franchise, which also includes the Cell Therapy franchise (Yescarta and Tecartus). The franchise saw an 18% sales growth in the first quarter of 2024.
6. Competition in the TROP2 ADC space: The failure of Trodelvy in the TROPiCS-04 study comes as competition in the TROP2 ADC space heats up, with AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) also failing to meet its primary endpoint in a similar setting.
7. Gilead's plans: Gilead will present full study data at an upcoming medical meeting and plans to further investigate the deaths due to adverse events. The company will also reiterate to physicians the importance of supporting treatment to prevent neutropenic complications.