Gilead announces updated results from three cohorts of TROPHY-U-01 study

Gilead announced new and updated results from three cohorts of the Phase 2 TROPHY-U-01 study of Trodelvy for the treatment of metastatic urothelial cancer, or mUC. These data demonstrate that Trodelvy produced both rapid and durable responses for patients across a range of hard-to-treat types of mUC including platinum-ineligible and rapidly progressing, post-platinum mUC. These findings will be featured in both an oral session and in poster presentations during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium, or ASCO-GU, Annual Meeting February 16-18. In April 2021, the U.S. FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or mUC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. This approval is based on ORR and DOR established in Cohort 1. Trodelvy has not been approved by any regulatory agency for the treatment of platinum-ineligible patients with mUC who progressed after prior CPI therapy, or in combination with pembrolizumab in patients with mUC who progressed after platinum-based therapy. Its safety and efficacy have not been established for these indications.