Study study type
PathologyT1T0Patientssample sizesROB Results

mUC - L1 - all population metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - all population

versus gemcitabine plus platin
atezolizumab alone
IMvigor-130 (At-arm B vs Ch-armC), 2020
  NCT02807636		RCTmUC - L1 - all populationatezolizumab (B)chemotherapy (C) gemcitabine plus platinepatients with untreated locally advanced or metastatic urothelial carcinoma360 / 400some concern
 inconclusive
  • inconclusive 2 % increase in deaths (OS) (PE)
  • statistically significant 62 % decrease in objective responses (ORR)
versus placebo plus SoC
atezolizumab plus SoC
IMvigor-130 (At-arm A vs Pl-arm C), 2020
  NCT02807636		RCTmUC - L1 - all populationatezolizumab (A) plus gemcitabine and platineplacebo (C) plus gemcitabine and platinepatients with untreated locally advanced or metastatic urothelial carcinoma451 / 400some concern
 conclusif
  • inconclusive 17 % decrease in deaths (OS) (PE)
  • demonstrated 18 % decrease in progression or deaths (PFS) (PE)

mUC - L2 - all population metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - all population

versus Standard of Care (SoC)
atezolizumab alone
IMvigor-211 (all population), 2018
  NCT02302807		RCTmUC - L2 - all populationatezolizumabchemotherapypatients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen patients had received no more than two previous lines of therapy and had progressed during or following one or more platinum-containing regimens for metastatic urothelial carcinoma (or neoadjuvant or adjuvant therapy with progression)467 / 464some concern
 suggested
  • suggested 15 % decrease in deaths (OS) (PE)
  • suggested 18 % decrease in deaths (OS) (extension)

mUC - L2 - PDL1 positive metastatic/advanced UC (mUC) - 2nd Line (L2) mUC - L2 - PDL1 positive

versus Standard of Care (SoC)
atezolizumab alone
IMvigor-211 (PDL1>5%), 2018
  NCT02302807		RCTmUC - L2 - PDL1 positiveatezolizumabchemotherapypatients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen patients had received no more than two previous lines of therapy and had progressed during or following one or more platinum-containing regimens for metastatic urothelial carcinoma (or neoadjuvant or adjuvant therapy with progression)116 / 118some concern
 inconclusive
  • inconclusive 13 % decrease in deaths (OS) (PE)
IMvigor-211 (PDL1>1%), 2018
  NCT02302807		RCTmUC - L2 - PDL1 positiveatezolizumabchemotherapypatients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen patients had received no more than two previous lines of therapy and had progressed during or following one or more platinum-containing regimens for metastatic urothelial carcinoma (or neoadjuvant or adjuvant therapy with progression316 / 309some concern
 suggested
  • inconclusive 13 % decrease in deaths (OS) (PE)

MIBC - NA - all population muscular invasive bladder cancer (MIBC) MIBC - (neo)adjuvant (NA) MIBC - NA - all population

versus no additional treatment
atezolizumab alone
IMvigor-010, 2021
  NCT02450331		RCTMIBC - (neo)adjuvant (NA)atezolizumabobservationpatients aged 18 years or older and had histologically confirmed muscle-invasiveurothelial carcinoma of either the bladder or the upper tract as Adjuvant Therapy (Participants With High-Risk Muscle-Invasive Urothelial Carcinoma)406 / 403some concern
 inconclusive
  • inconclusive 11 % decrease in events or deaths (EFS) (PE)

 

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