Table Info

Table 1.

Comparison between phase III front-line UC trials

Trial	Experimental arm vs. standard arm	Primary endpoint	Secondary endpoints	Toxicity	US FDA approval
JAVELIN Bladder 100 [19]	Gem/cis or carbo followed by avelumab + BSC vs. BSC	Updated mOS: 23.8 mos (Ave) vs. 15 mos (BSC); OS at 1 year: 71.3% (Ave) vs. 58.4% (BSC)	mPFS: 5.5 mos (Ave) vs. 2.1 mos (BSC); updated 2-year PFS: 23.4% (Ave) vs. 7.1% (BSC); trAE: 98.3% pts (Ave group) vs. 77.0% pts (BSC); at eligibility: CR 25.7%; PR = 46.6%; SD = 27.7%	Grade >/= 3: Ave (47.4%) vs. BSC (77.7%); Ave included: UTI (4.4%), anemia (3.8%), hematuria (1.7%), fatigue (1.7%), back pain (1.2%), vomiting (1.2%)	June 30, 2020: Ave maintenance treatment of pts with la or mUC that has not progressed with first-line platinum-containing chemotherapy
EV-302 [15]	EV+P vs. gem/cis or carbo	mOS: 31.5 mos (EV+P group) vs. 16.1 mos (chemotherapy group); PFS: 12.5 mos (EV+P group) vs. 6.3 mos (chemotherapy group)	ORR: 67.7% (CR = 29.1%) in the EV+P vs. 44.4% (CR = 12.5%) in the chemotherapy group; TTP: 14.2 mos (EV+P group) vs. 10.0 mos (chemotherapy group)	Grade >/= 3 trAE: 55.9% with EV+P vs. 69.5% with chemotherapy; EV+P grade >/= 3 included: rash (7.7%), hyperglycemia (5.0%), neutropenia (4.8%)	December 15, 2023: EV+P for pts with locally advanced or mUC
CheckMate 901 (sub-study) [16]	Gem/cis + nivo vs. gem/cis	mOS: 21.7 mos (GC + nivo) vs. 18.9 mos (gem/cis); PFS at 12 mos: 34.2% (GC + nivo) vs. 21.8% (gem/cis)	ORR: 57.6% (CR = 21.7%) GC + nivo vs. 43.1% (CR = 11.8%) GC; OS and PFS in PD-L1 expression of >/= 1% favored GC + nivo (HR: 0.75, 95% CI: 0.53 to 1.06) over GC group (HR: 0.60, 95% CI: 0.41 to 0.81)	Grade >/= 3 AE: 61.8% of gem/cis + nivo group vs. 51.7% in gem/cis group; trAE with gem/cis + nivo were anemia (57.2%), nausea (46.7%), and neutropenia (30.6%)	March 6, 2024: GC + nivo for first-line treatment of pts with unresectable or mUC

Ave: avelumab; cis: cisplatin; carbo: carboplatin; gem: gemcitabine; nivo: nivolumab; EV: enfortumab vedotin; EV+P: enfortumab vedotin plus pembrolizumab; BSC: best supportive care; PFS: progression-free survival; OS: overall survival; mOS: median overall survival; mos: months; ORR: objective response rates; TPP: time to pain progression; mUC: metastatic urothelial carcinoma; trAE: treatment-related adverse events; la: locally advanced; AE: adverse events; GC: gemcitabine/cisplatin; UTI: urinary tract infection; TTP: time to progression; HR: hazard ratios; CI: confidence intervals; pts: patients; CR: complete response; SD: stable disease; PR: partial response; PD-L1: programmed death ligand-1

Declarations

Author contributions

JBAC: Conceptualization, Investigation, Writing—original draft, Writing—review & editing, Supervision. MA and EMY: Investigation, Writing—original draft, Writing—review & editing. All authors read and approved the submitted version.

Conflicts of interest

JBAC declares Speakers’ Bureau fees from EMD Serono, Astellas/Seagen, Pfizer, Merck, Bristol Myers Squibb; advisory board fees from Merck, EMD Serono, Pfizer/Seagen, Astellas, AZD, Immunomedics, Novartis, Janssen, Bayer. MA and EMY have no conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

Not applicable.

Copyright

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