FDA Approves Sacituzumab Govitecan for Advanced Urothelial Cancer

Urothelial carcinoma cells.

Sacituzumab govitecan (Trodelvy®, Immunomedics) has been granted accelerated approval for patients with locally advanced or metastatic urothelial cancer following treatment with platinum–containing chemotherapy and a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitor.

“Patients with metastatic urothelial cancer have limited options after progression on platinum and checkpoint inhibitors,” wrote the investigators of the phase 2 TROPHY-U-01 study (NCT03547973), on which the approval was based, led by first author Yohann Loriot, MD, PhD, a medical oncologist at the Institut Gustave Roussy in France. “Sacituzumab govitecan is an antibody-drug conjugate composed of a humanized immunoglobulin G1 kappa anti–Trop-2 monoclonal antibody coupled to SN-38 via a unique hydrolyzable linker.”

TROPHY-U-01 enrolled 112 patients with locally advanced or metastatic urothelial carcinoma previously treated with platinum–containing chemotherapy and a PD-1/PD-L1 inhibitor. Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and had a creatinine clearance of ≥30 mL/minute. Patients had received a median of three prior therapies, and 62% had visceral metastases. All eligible patients received 10 mg/kg sacituzumab govitecan intravenously on Days 1 and 8 of a 21-day treatment cycle. The primary end point was objective response rate as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, with secondary end points of progression-free survival, overall survival, duration of response, and safety.

Sacituzumab govitecan produced an overall response rate of 27.7% and a complete response rate of 5.4%. Among patients who responded, the median duration of response was 7.2 months.

Adverse events occurring in more than 25% of patients receiving sacituzumab govitecan included neutropenia, nausea, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, decreased appetite, rash, and abdominal pain. The prescribing information for sacituzumab govitecan includes a warning that severe neutropenia and diarrhea may occur.

“Sacituzumab govitecan demonstrated meaningful efficacy with manageable toxicity,” concluded Dr. Loriot and colleagues in their presentation of the trial’s final results at the European Society for Medical Oncology Virtual Congress in September 2020.

The recommended dose of sacituzumab govitecan is 10 mg/kg once weekly on Days 1 and 8 of each 21-day treatment cycle, administered intravenously, until disease progression or unacceptable toxicity.

For More Information

Loriot Y, Balar AV, Petrylak DP, et al (2020). TROPHY-U-01 cohort 1 final results: a phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI). Ann Oncol (ESMO Virtual Congress Abstracts), 31(suppl_4): S1142-S1215. DOI: 10.1016/j.annonc.2020.08.2253

Clinicaltrials.gov (2021). Phase II open label, study of IMMU-132 in metastatic urothelial cancer. NLM identifier: NCT03547973.

Trodelvy® (sacituzumab govitecan-hziy) prescribing information (2021). Immunomedics. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761115s009lbl.pdf

US Food & Drug Administration (2021). FDA grants accelerated approval to sacituzumab govitecan for advanced urothelial cancer. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sacituzumab-govitecan-advanced-urothelial-cancer

Image credit: Nephron. Licensed under CC BY-SA

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