- 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.
- 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.
- 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.
- Small study.