- Enfortumab vedotin achieved a 44% objective response rate (ORR) in patients with metastatic/locally advanced urothelial carcinoma refractory to both platinum chemotherapy and anti-programmed death 1 or anti-programmed death ligand 1 (PD-1/L1) therapy.
Why this matters
- Findings form basis of submission to US Food and Drug Administration for accelerated approval.
- A phase 3 trial is underway.
- Phase 2 EV-201 study evaluated enfortumab vedotin in 125 patients with locally advanced (n=13) or metastatic (n=112) urothelial carcinoma previously treated with platinum-based chemotherapy and anti-PD-1/L1 therapy.
- Funding: Seattle Genetics, Astellas Pharma.
- Median follow-up was 10.2 months.
- Confirmed ORR was 44% (complete response, 12%).
- Median time to response was 1.84 months and duration of response was 7.6 (range, 0.95-11.3+) months.
- Objective responses were observed in:
- patients with liver metastases (38%);
- patients treated with ≥3 prior lines;
- prior anti-PD-1/L1 therapy responders (56%) and nonresponders (41%).
- Estimated median PFS was 5.8 (95% CI, 4.9-7.5) months.
- OS was 11.7 (95% CI, 9.1-not reached) months.
- Treatment-related adverse events (TRAEs) included fatigue (50%), any peripheral neuropathy (50%), alopecia (49%).
- Most common grade ≥3 TRAEs were neutropenia (8%), anemia (7%), and fatigue (6%).
- 32% of patients required dose reduction and 12% discontinued treatment.
- Single-arm study.