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Nab-paclitaxel plus pembrolizumab produced an encouraging overall response rate with manageable safety in patients with advanced urothelial cancer who were refractory to platinum-based chemotherapy or cisplatin ineligible, according to data from the phase 2 ABLE trial.
Effective treatment paths leveraging neoadjuvant chemotherapy have been well-established for patients with muscle-invasive bladder cancer, with mounting retrospective and prospective data continuing to demonstrate overall survival benefit compared with adjuvant chemotherapy.
Patients with metastatic urothelial carcinoma have multiple effective treatment options approved in both the first line and relapsed settings, with other promising agents and combinations currently in development.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has confirmed its recommendation to approve the use of enfortumab vedotin in adult patients with locally advanced or metastatic urothelial cancer who have received prior platinum-based chemotherapy and a PD-1/PD-L1 inhibitor.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for use as an adjuvant treatment in adult patients with muscle-invasive urothelial carcinoma with a PD-L1 expression of at least 1% on tumor cells, who are at a high risk of recurrence following radical resection.
The addition of atezolizumab to neoadjuvant gemcitabine and cisplatin generated a high rate of non–muscle-invasive downstaging following radical cystectomy, which correlated with improved relapse-free survival and overall survival in patients with muscle-invasive bladder cancer, according to data from a phase 2 trial.
Enfortumab vedotin produced promising antitumor activity when used as neoadjuvant treatment in patients with muscle invasive bladder cancer who were not eligible for cisplatin.
The addition of olaparib to durvalumab did not result in a significant prolongation in progression-free survival compared with durvalumab alone in patients with previously untreated, platinum-ineligible metastatic urothelial carcinoma.
Second-line sacituzumab govitecan plus pembrolizumab generated promising antitumor activity in patients with checkpoint inhibitor–naïve metastatic urothelial cancer.
Niraparib in combination with cabozantinib demonstrated a manageable safety profile, with preliminary efficacy observed in heavily pretreated patients with metastatic urothelial carcinoma.
Avelumab failed to demonstrate an improvement in overall survival at 1 year as frontline treatment in patients with cisplatin-ineligible, PD-L1–positive advanced urothelial cancer, though it did elicit a notable objective response rate.
The frontline maintenance combination of avelumab plus best supportive care continued to show an improvement in overall survival compared with BSC alone in patients with metastatic urothelial cancer who receive first-line chemotherapy.
The combination of lenvatinib and pembrolizumab elicited comparable antitumor activity compared with placebo plus pembrolizumab as frontline therapy in patients with advanced urothelial carcinoma who were ineligible for platinum-based chemotherapy, according to data from LEAP-011.