Sacituzumab govitecan (SG) exhibited activity in patients with metastatic urothelial carcinoma (mUC) who progressed after receiving immune checkpoint inhibitors and platinum-based chemotherapy, according to phase 2 results published in the Journal of Clinical Oncology.  

The phase 2 TROPHY-U-01 trial ( Identifier: NCT03547973) included 113 patients with mUC. At baseline, the patients’ median age was 66 years (range, 33-90 years), 78% were men, 66.4% had visceral disease, and 33.6% had liver metastases.

The patients had previously received a median of 3 prior anticancer regimens (range, 1-8). All but 1 patient had received immune checkpoint inhibitor treatment, 24 had received carboplatin-based chemotherapy, and 89 had received cisplatin-based chemotherapy.

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For the current study, patients received a median of 6 cycles of SG (11 doses; range, 1-56 doses). The median treatment duration was 3.7 months (range, 0-20 months), and the median follow-up was 9.1 months (range, 0-19.9 months).

A majority of patients discontinued SG treatment (n=103), most due to disease progression (n=81).

Still, SG yielded responses in all subgroups of patients, including those with more than 2 prior lines of therapy and those with visceral and liver metastases.

The overall response rate was 27.4%, with 6 patients achieving a complete response and 25 having a partial response. The median duration of response was 7.2 months, and the median time to response was 1.6 months.

The median progression-free survival was 5.4 months, and the median overall survival was 10.9 months.

The most common treatment-related adverse events (TRAEs) were diarrhea (65%), nausea (60%), fatigue (52%), alopecia (47%), neutropenia (46%), decreased appetite (36%), anemia (33%), vomiting (30%), and leukopenia (25%).

The most common grade 3 or higher TRAEs were neutropenia (35%), leukopenia (18%), anemia (14%), diarrhea (10%), and febrile neutropenia (10%).

TRAEs led to treatment discontinuation in 6% of patients.  

“SG is an active drug with a manageable safety profile…,” the study authors wrote. “The results from this study supported accelerated approval of SG in this population.”

Disclosures: This research was supported by Immunomedics Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: A phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J Clin Oncol. 2021;39(22):2474-2485. doi:10.1200/JCO.20.03489