Urothelial cancer: enfortumab vedotin active after platinum, anti-PD-1/L1 therapy

  • Rosenberg JE & al.
  • J Clin Oncol
  • 29 Jul 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Single-arm study.