Gilead’s Trodelvy Stumbles in Late-Stage Trials But Remains Prized Cancer Asset

Medicine vial/Nicole Bean

Pictured: Medicine vial over rock pile with complex data background/ Nicole Bean for BioSpace

Gilead Sciences encountered a major setback in late May when its antibody-drug conjugate Trodelvy failed to reach the primary endpoint in a confirmatory Phase III trial in patients with metastatic urothelial cancer. In addition to missing the mark in overall survival, Gilead reported a higher number of deaths in the Trodelvy arm of the study. However, Wall Street analysts are still optimistic when it comes to the drug’s blockbuster potential as a future cornerstone of Gilead’s oncology franchise.

TROPiCS-04 was the late-stage confirmatory trial meant to upgrade Trodelvy’s accelerated approval in previously-treated urothelial carcinoma (UC), which was granted by the FDA in 2021. The study compared Trodelvy to chemotherapy as a second-line treatment for patients with locally advanced or metastatic UC (mUC). The bottom line: the TROP2-directed antibody-drug…
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