Table 2 Novel regimens under investigation—urothelial cancer highlights from ASCO 2023

[17]

EV103

1b/2

Enfortumab vedotin + Pembrolizumab

45

Patients with metastatic urothelial carcinoma who were cisplatin ineligible

73.3% (58.1–85.4)

12.7 mos

26.1 mos

64.4% with Grade III toxicity, primarily elevated lipase, maculo-papular rash, and fatigue

[18]

THOR

3

Erdafitinib versus chemotherapy (investigator’s choice) in patients with FGFRalt

266

Patients with urothelial carcinoma with FGFRalt on 2nd or 3rd line therapy

45.6 versus 11.5

5.6 versus 2.7

12.1 versus 7.8 mos

Serious treatment-related events 13% with Erdafitinib versus 24% in chemotherapy arm

[19]

Norse

2

Erdafitinib compared to Erdafitinib + Cetrelimab in metastatic urothelial carcinoma with presence of FGFRalt

87

Patients with metastatic urothelial carcinoma with FGFRalt and are cisplatin ineligible

54.5% in combination versus 44.2% in ERDA alone

10.97 mos versus 5.62 mos

-

1 death in combination group from pulmonary failure, otherwise no added toxicity with addition of Cetrelimab to ERDA