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Evolution of First-Line Therapy in Cisplatin-Ineligible mUC
Atezolizumab accelerated
FDA approval Prior to
April, 2017 Gemcitabine-Carboplatin
IMvigor 210 (Cohort 1)ORR
23%, Median OS 15.9mo April, 2017 ORR36%
Median DoR NR Median OS ~ 9 months
May, 2017
Pembrolizumab
accelerated FDA Gemcitabine-Carboplatin
approval followed by avelumab
KEYNOTE-052 maintenance (preferred)
ORR 24%,Median JAVELIN Bladder 100
DoR, NR June, 2018 NOW
Pembrolizumab label
restricted to ”platinum-
FDA restricted atezo and pembro ineligible” mUC ONLY after
to cisplatin-ineligible with high PD- FDA ODAC meeting in
L1 expressing tumors OR those who August, 2021
are “platinum-ineligible” De Santis M et al. JCO 2021
.Balar AV Lancet 2017
Balar AV et al. Lancet 2017
Powles T et al. NEJM 2020
