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Gilead’s phase 3 TROPiCS-04 study of Trodelvy for treating locally advanced or metastatic urothelial cancer fails to meet primary endpoint

Gilead Sciences, Inc. released findings from the phase 3 TROPiCS-04 study in metastatic urothelial cancer (mUC), comparing Trodelvy (SG) to chemotherapy in patients who received prior treatment. While not meeting its primary endpoint of overall survival (OS) in the ITT population, Trodelvy showed improved OS trends and positive results in select subgroups and secondary endpoints like progression-free survival (PFS) and overall response rate (ORR). However, Trodelvy had more deaths due to adverse events, primarily neutropenic complications.

Gilead will further investigate these findings and emphasize using granulocyte-colony stimulating factor (G-CSF) to prevent neutropenia. Trodelvy's safety profile remains consistent. It has accelerated approval for certain mUC patients in the US, pending confirmation in confirmatory trials like TROPiCS-04. Trodelvy, a Trop-2-directed antibody-drug conjugate, holds promise in various cancers expressing Trop-2, including breast, bladder, and lung cancers.