Bladder Cancer Coverage from Every Angle

Enfortumab Vedotin in Previously Treated Advanced Urothelial Cancer: Update From EV-201

By: Susan Reckling
Posted: Friday, October 30, 2020

The prognosis is poor for patients with locally advanced or metastatic urothelial carcinoma, particularly if the disease has progressed on or after platinum-based chemotherapy. However, based on longer follow-up from the EV-201 trial, the Nectin-4–directed antibody-drug conjugate enfortumab vedotin may prove to be an effective alternative for these patients.

Peter O’Donnell, MD, of the University of Chicago, and colleagues reported that half of the patients treated with this novel immunotherapy were alive at 12 months. One-third of the patients were alive at 18 months. These findings were presented as an e-poster at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 746P). In December 2019, the U.S. Food and Drug Administration granted this agent's accelerated approval in this patient population.

A total of 125 patients took part in this open-label, multicenter study. Patients' median age was 69, and patients had received a median of three prior systemic therapies. The dose of enfortumab vedotin was 1.25 mg/kg, and it was given on days 1, 8, and 15 of each 28-day cycle. The median follow-up was 22.3 months.

The investigators reported a median overall survival of 12.4 months (95% confidence interval = 9.46–15.57 months). At 12 months, the overall survival rate was 50.4%, and at 18 months, it was 34.2%. The median treatment duration was 4.6 months, and the maximum treatment duration was 27.3 months and ongoing at the time of data cutoff.

As for toxicity, alopecia, fatigue, and decreased appetite were the most common treatment-related adverse events, occurring in 49.6%, 49.6%, and 44% of study patients, respectively. In addition, approximately half of treatment patients experienced skin reactions and peripheral neuropathy.

Disclosure: For full disclosures of the study authors, visit

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