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Advancements in Therapy for Bladder Cancer: Enfortumab Vedotin.

ABSTRACT: The treatment paradigm for urothelial carcinoma (UC), a common genitourinary cancer, has significantly expanded in recent years. Enfortumab vedotin, a Nectin-4-targeted antibody-drug conjugate, was recently approved by the U.S. Food & Drug Administration for patients with advanced or metastatic UC following chemotherapy and immunotherapy. Approval of enfortumab vedotin was based on findings from the EV-201 trial, which demonstrated objective response rates of 44%. Patients treated with enfortumab vedotin should be monitored for specific toxicities, including peripheral neuropathy, rash, and hyperglycemia. In this article, the clinical implications of enfortumab vedotin for the treatment of advanced UC are reviewed.

SUBMITTER: Hanna KS

PROVIDER: S-EPMC7863123 | biostudies-literature | 2020 May-Jun

REPOSITORIES: biostudies-literature

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Advancements in Therapy for Bladder Cancer: Enfortumab Vedotin.

Hanna Kirollos S KS

Journal of the advanced practitioner in oncology 20200501 4

The treatment paradigm for urothelial carcinoma (UC), a common genitourinary cancer, has significantly expanded in recent years. Enfortumab vedotin, a Nectin-4-targeted antibody-drug conjugate, was recently approved by the U.S. Food & Drug Administration for patients with advanced or metastatic UC following chemotherapy and immunotherapy. Approval of enfortumab vedotin was based on findings from the EV-201 trial, which demonstrated objective response rates of 44%. Patients treated with enfortuma ...[more]

PMID: 33604101

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Project description:BackgroundPatients with advanced urothelial carcinoma have poor overall survival after platinum-containing chemotherapy and programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor treatment.MethodsWe conducted a global, open-label, phase 3 trial of enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-containing chemotherapy and had had disease progression during or after treatment with a PD-1 or PD-L1 inhibitor. Patients were randomly assigned in a 1:1 ratio to receive enfortumab vedotin (at a dose of 1.25 mg per kilogram of body weight on days 1, 8, and 15 of a 28-day cycle) or investigator-chosen chemotherapy (standard docetaxel, paclitaxel, or vinflunine), administered on day 1 of a 21-day cycle. The primary end point was overall survival.ResultsA total of 608 patients underwent randomization; 301 were assigned to receive enfortumab vedotin and 307 to receive chemotherapy. As of July 15, 2020, a total of 301 deaths had occurred (134 in the enfortumab vedotin group and 167 in the chemotherapy group). At the prespecified interim analysis, the median follow-up was 11.1 months. Overall survival was longer in the enfortumab vedotin group than in the chemotherapy group (median overall survival, 12.88 vs. 8.97 months; hazard ratio for death, 0.70; 95% confidence interval [CI], 0.56 to 0.89; P = 0.001). Progression-free survival was also longer in the enfortumab vedotin group than in the chemotherapy group (median progression-free survival, 5.55 vs. 3.71 months; hazard ratio for progression or death, 0.62; 95% CI, 0.51 to 0.75; P<0.001). The incidence of treatment-related adverse events was similar in the two groups (93.9% in the enfortumab vedotin group and 91.8% in the chemotherapy group); the incidence of events of grade 3 or higher was also similar in the two groups (51.4% and 49.8%, respectively).ConclusionsEnfortumab vedotin significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-based treatment and a PD-1 or PD-L1 inhibitor. (Funded by Astellas Pharma US and Seagen; EV-301 ClinicalTrials.gov number, NCT03474107.).

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Advancements in Therapy for Bladder Cancer: Enfortumab Vedotin.

Publications

Advancements in Therapy for Bladder Cancer: Enfortumab Vedotin.

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