Gilead (NASDAQ: GILD) has announced that a late-stage study for its antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) did not meet the primary endpoint of overall survival (OS) in patients with previously treated locally advanced or metastatic urothelial cancer (mUC). This result casts uncertainty over the drug’s accelerated approval indication in the US for the treatment of locally advanced or metastatic UC, which was dependent on successful confirmatory trials, including this study.
The trial data highlighted a higher number of deaths attributed to adverse events with Trodelvy compared with the treatment of physicians’ choice. However, Gilead emphasized that there were no new safety signals that would alter the known safety profile of the drug for its previously approved indications. These include triple-negative breast cancer (TNBC) and HR+/HER2- metastatic breast cancer.
Trodelvy, a Trop-2 directed ADC, continues to be investigated in other cancer types, including metastatic non-small cell lung cancer (NSCLC), head and neck cancer, gynecological cancer, and gastrointestinal cancers.- Flcube.com
