ASCO-GU 2020 — Enfortumab vedotin plus pembrolizumab shows promise in bladder cancer


  • Deepa Koli
  • Univadis
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Takeaway

  • First-line enfortumab vedotin (EV) plus pembrolizumab shows promising activity in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.
  • High response was reported regardless of programmed cell death ligand 1 (PD-L1) status.

Why this matters

  • Gemcitabine-carboplatin, standard-of-care in these patients, has a poor response rate.
  • Findings need prospective validation in large studies.

Study design

  • Durability data from the dose-escalation and expansion cohorts of the EV-103 trial.
  • A total of 45 cisplatin-ineligible, treatment-naïve patients with locally advanced or metastatic urothelial carcinoma (median age, 69 years; 80% were male) received enfortumab vedotin+pembrolizumab.
  • Primary endpoint: safety/tolerability; secondary objectives included determination of recommended EV dose, ORR, DCR, DOR/PFS (per RECIST v1.1), and OS
  • Funding: Seattle Genetics, Inc.

Key results

  • 91% of patients had visceral disease.
  • Median follow-up duration, 10.4 months.
  • Median DOR: not reached.
  • The confirmed ORR was 73.3%, including 15.6% complete responses and 57.8% partial responses.
  • ORR in patients with available PD-L1 status: high PD-L1, 78.6%; low PD-L1, 63.2%. 
  • Median PFS: 12.3 months (95% CI, 7.98-not reached).
  • Median OS was not reached, and the 12-month OS rate was 81.6%.
  • No new safety signals were reported.
  • The most common treatment-related adverse events were fatigue, alopecia, and peripheral sensory neuropathy.
  • Serious adverse event rate was 16%; 1 treatment-related death was observed.

Limitations

  • Small study.