OBJECTIVES: EV-103 is a Phase 1b/2 open-label, multi-cohort trial of enfortumab vedotin (EV), alone or in combination, for urothelial carcinoma (NCT03288545). EV-103 Cohort H exit interviews evaluated patient experiences before/after EV neoadjuvant treatment in patients with muscle-invasive bladder cancer (MIBC) ineligible for cisplatin.

METHODS: Enrolled patients (aged ≥18 years) received EV on Day (D) 1 and 8 in three 21-day cycles (C) followed by radical cystectomy and pelvic lymph node dissection. Pre-cystectomy interviews on MIBC impacts and treatment experience occurred post-EV (C3D15) and prior to cystectomy; post-cystectomy interviews on perceptions of benefits/risks of EV occurred 31–45 days post-surgery.

RESULTS: Fourteen of 22 enrolled patients completed ≥1 interview (10 completed both). Mean (SD) age was 72.9 (6.4) years; 85.7% were male. During pre-cystectomy interviews (n=13), most frequent baseline symptoms pre-EV included haematuria (92.3%), pain (53.8%), nocturia (46.2%), fatigue (38.5%), and increased urinary frequency (38.5%); most frequent MIBC impacts pre-EV were reduced emotional wellbeing (53.8%) and decreased sex life (15.4%). Most patients (80%) found EV administration “fine/good/pleasant”. Post-EV and compared with baseline, 9/12 patients (75.0%) reported an improvement in haematuria, 3/7 (42.9%) reported less pain intensity in ≥1 aspect of pain. Most patients (69.2%) were willing to continue EV. Patient-reported AEs included rash (76.9%), fatigue, and loss of taste (both 69.2%). During post-cystectomy interviews (n=11), patients reported improved health (45.5%) or mostly recovered (27.3%). Most patients (63.6%) would undergo additional EV treatment if recommended or more cycles (85.7%) to achieve pathologic complete response (pCR); but would not delay surgery for more cycles without increased likelihood of pCR.

CONCLUSIONS: Patients reported measurable change in haematuria and pain. Overall, EV was well tolerated with no new safety signals observed. Most patients were willing to continue treatment if it led to better outcomes. These insights into patient experience can inform future trials in MIBC, especially selection of patient-reported outcomes.