. 2021 Jun 11;26(8):e1381–e1394. doi: 10.1002/onco.13827

Table 3.

Efficacy outcomes of select phase II first‐line trials in cisplatin‐ineligible metastatic urothelial carcinoma

Trial ID Phase	Regimen(s)	n	Median follow‐up, months	Overall response rate, (95% CI), %	Median DoR (95% CI), months	Median progression‐free survival, (95% CI), months	Median overall survival (95% CI), months
KEYNOTE‐052 single‐arm phase II [51, 67]	Pembrolizumab 200 mg D1, q3w (up to 24 months)	370	24 (minimum)	28.6 (24.1–33.5)	30.1(18.1–NYR)	2.2 (2.1–3.4)	11.3 (9.7–13.1)
KEYNOTE‐052 single‐arm phase II [51, 67]	Pembrolizumab 200 mg D1, q3w (up to 24 months)	PD‐L1 CPS ≥10: 110	24 (minimum)	47.3 (37.7–57.0)	NYR (18.1–NE)	NR	18.5 (12.2–28.5)
IMvigor 210 multicohort phase II cohort 1 [50]	Atezolizumab 1,200 mg D1, q3w	119	17.2	23 (16–31)	NYR	2.7 (2.1–4.2)	15.9 (10.4–NE)
IMvigor 210 multicohort phase II cohort 1 [50]	Atezolizumab 1,200 mg D1, q3w	PD‐L1 IC2/3: 32	17.2	28 (14–47)		4.1 (2.3–11.8)	12.3 (6.0–NE)
EV‐103 multicohort phase I/II cohort A [51]	Enfortumab vedotin 1.25 mg/kg D1,8 + pembrolizumab 200 mg D1, q3w	45	11.5	73.3 (58.1–85.4)	NYR [1.2–12.9+]	12.3 (8.0–NE)	NYR (range, 0.66–19.2+)
EV‐103 multicohort phase I/II cohort A [51]		PD‐L1 CPS ≥10: 14	11.5	CPS ≥10: 78.6 (Primary endpoint safety)	NYR [1.2–12.9+]	12.3 (8.0–NE)	NYR (range, 0.66–19.2+)

Efficacy outcomes of select phase I–II targeted therapy trials in urothelial carcinoma ordered by size of trial.

Abbreviations: CI, confidence interval; CPS, combined positive score; D, day; DoR, duration of response; IC, immune cells; ID, identifier; NE, not estimable; NR, not reported; NYR, not yet reached; PD‐L1, programmed death ligand; qXw, every X weeks.