Urothelial Cancer

Combining the antibody drug conjugate, enfortumab vedotin (Padcev) with the immune checkpoint inhibitor pembrolizumab (Keytruda) showed encouraging results in patients with locally advanced or metastatic uro­thelial cancer who were unable to receive cisplatin-based chemotherapy in the first-line setting.

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Preliminary results from a single-arm study demonstrated promising progression-free survival (PFS) and a clinically meaningful objective response rate (ORR) with the combination of pembrolizumab (Keytruda) and nab-paclitaxel (Abraxane) as second- or third-line therapy in patients with advanced urothelial carcinoma.

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On June 30, 2020, the FDA approved avelumab (Bavencio; Pfizer) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. This approval was based on results of the randomized, multicenter, open-label, phase 3 JAVELIN Bladder clinical trial. This study enrolled 700 patients with unresectable, locally advanced, or metastatic urothelial carcinoma that had not progressed with 4 to 6 cycles of first-line platinum-containing chemotherapy. Patients were randomized to avelumab given intravenously every 2 weeks plus best supportive care (BSC) or BSC alone.

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Mitomycin gel (Jelmyto), an alkylating drug, is the first and only FDA-approved treatment for patients with low-grade upper-tract urothelial cancer (UTUC), a rare cancer that affects the lining of the urinary system, and offers a nonsurgical treatment alternative for patients with this rare disease. Although the majority of urothelial cancers occur in the bladder, UTUC is part of a group of urothelial cancers that arise in the lining of the kidney or the ureter. Read More ›

Patients with metastatic urothelial cancer receive first-line treatment with platinum-based chemotherapy and second-line treatment with a checkpoint inhibitor. There is currently no approved third-line therapy for this malignancy. The investigational antibody-drug conjugate enfortumab vedotin may be a good choice for third-line therapy, based on the results of a phase 2 clinical trial presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

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Sacituzumab govitecan, a novel antibody-drug conjugate directed against Trop-2, induced responses in nearly 33% of patients with heavily pretreated, relapsed or refrac­tory metastatic urothelial cancer. Read More ›

Adjuvant chemotherapy had impressive gains in disease-free survival (DFS) and metastasis-free survival versus surveillance in upper-tract urothelial cancer (UTUC), according to the results of the phase 3 POUT clinical trial that were presented at the 2018 Genitourinary Cancers Symposium. Read More ›

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