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Enfortumab vedotin as a promising treatment option for bladder cancer: phase 2 results

Presented By
Dr Arjun Vasant Balar, NYU Langone Medical Oncology, USA
ASCO GU 2021
Interim data from the phase 2 EV-201 trial investigating the efficacy of enfortumab vedotin on bladder cancer is promising. In cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer (la/mUC) who had received prior therapy with an immune checkpoint inhibitor, 52% of participants achieved a confirmed objective response rate (ORR) after receiving enfortumab vedotin therapy [1].

Nectin-4 is a cell-adhesion molecule that is highly expressed in urothelial carcinoma and may contribute to tumour-cell growth and proliferation. Enfortumab vedotin, an antibody–drug conjugate directed against nectin-4, is composed of a fully human monoclonal antibody specific for nectin-4 and monomethyl auristatin E (an agent that disrupts microtubule formation) [2].

The ongoing EV-201 trial (NCT03219333) is investigating the efficacy and safety of enfortumab vedotin administered to patients with la/mUC who have previously been treated with PD-1/PD-L1 inhibitors. The study has 2 cohorts: patients who have undergone platinum-based chemotherapy and patients who are cisplatin-ineligible/platinum-naïve. Dr Arjun Vasant Balar (NYU Langone Medical Oncology, New York, USA) shared results from the second cohort at ASCO GU 2021.

The cisplatin-ineligible cohort consisted of 89 participants who received 1.25 mg/kg enfortumab vedotin intravenously on days 1, 8, and 15 of each 28-day cycle for a median treatment duration of 6 months. The primary endpoint was ORR utilised Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 confirmed by an independent review facility. ORR was achieved by 52% of the participants and 20% of participants achieved a complete response. Median duration of response was 10.9 months, median progression-free survival was 5.8 months, and median overall survival was 14.7 months.

The safety profile matched the pre-existing safety profile of enfortumab vedotin. Four deaths were deemed to be treatment related; all occurred in patients aged >75 with multiple co-morbidities. Causes of death were acute kidney injury, metabolic acidosis, multiple organ dysfunction syndrome, and pneumonitis. Adverse events included alopecia areata (51%), peripheral neuropathy (47%), fatigue (34%), rash (61% all grade), and hyperglycaemia (10% all grade).

The researchers are optimistic that the favourable ORR and safety profile of enfortumab vedotin will make it a reasonable therapeutic option in the management of patients with la/mUC who have failed previous lines of therapy.

  1. Balar A. EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with local advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors. Abstract 394, ASCO Genitourinary Cancers Symposium, 11–13 February 2021.

  2. Powles T, et al. N Eng J Med 2021; DOI: 10.1056/NEJMoa2035807. Online ahead of print.


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