Retrospective, Observational Analysis of Real-World Safety Outcomes in Patients With Locally Advanced/Metastatic...

Real-world data can inform sequencing and safety of treatments as the landscape of locally advanced/metastatic urothelial carcinoma (la/mUC) rapidly evolves. Sacituzumab govitecan (SG), a Trop-2-directed antibody drug conjugate, has clinical activity in refractory la/mUC. We conducted a retrospective, observational study to characterize SG safety and treatment patterns in patients with la/mUC.

The US-based Flatiron Health Research Database of de-identified electronic health records from patients > 18 years with la/mUC initiating SG (December 2019-July 2023) was utilized. Data on treatment patterns, real-world adverse events (rwAEs) of interest including neutropenia incidence, treatment discontinuation, and granulocyte colony-stimulating factor (G-CSF) use were summarized.

Of 220 SG-treated patients, 81% received SG in third line or later; 63% had received enfortumab vedotin (EV) in the prior treatment line. The most common rwAEs were diarrhea (50%), neutropenia (35%), and nausea (35%). Prevalence of febrile neutropenia and infections secondary to neutropenia was 8% and 4%, respectively. General toxicities and prespecified rwAEs of interest led to discontinuation in 9% and 3% of patients, respectively. Of 79 patients with neutropenia, 14 (18%) had received primary G-CSF and 65 (82%) had received secondary G-CSF; those who received primary G-CSF had lower rates of severe neutropenia.

In this real-world analysis of SG use in la/mUC in patients largely pretreated with EV, rwAEs were consistent with known SG safety profile. Primary G-CSF prophylaxis was associated with low incidence of severe neutropenia. These findings inform current and future studies of SG alone or in combination in patients with UC.