Posted: Monday, June 6, 2022
Neoadjuvant therapy with enfortumab vedotin-ejfv monotherapy demonstrated antitumor activity in patients with muscle-invasive bladder cancer who are cisplatin-ineligible, a subset of patients with a high unmet need for safe and effective neoadjuvant therapy. Daniel P. Petrylak, MD, of Yale Cancer Center, New Haven, Connecticut, and colleagues presented these findings from Cohort H of the EV-103 trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4582). Enfortumab vedotin is an antibody-drug conjugate directed to Nectin-4, a tumor-associated antigen that is highly expressed in urothelial cancer.
This phase Ib/II trial enrolled 22 patients with cisplatin-ineligible, muscle-invasive bladder cancer who had clinical stage T2 to T4a N0 M0 disease and were eligible for radical cystectomy and pelvic lymph node dissection. Patients received three cycles of neoadjuvant enfortumab vedotin at 1.25 mg/kg on days 1 and 8 of every 3-week cycle prior to surgery.
Clinical stage T2, T3, and T4 tumors were reported in 68.2%, 27.3%, and 4.5%, respectively. Many patients (68.2%) had predominant urothelial cancer.
A pathologic complete response was seen in 36.4% of patients, and pathologic tumor downstaging was observed in 50% of patients. As for safety, the adverse events were consistent with the known profile of enfortumab vedotin. The most common treatment-related adverse events included fatigue (45.5%), alopecia (36.4%), and dysgeusia (36.4%). A total of 18.2% patients reported grade ≥ 3 enfortumab vedotin treatment–related adverse events.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.