Study study type PathologyT1T0Patientssample sizesROB Results

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)
pembrolizumab alone
KEYNOTE-045 (all population), 2017
  NCT02256436
RCTmUC - L2 - all populationpembrolizumabchemotherapy (ICC) : paclitaxel, docetaxel, or vinfluninepatients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy treated as second-line therapy270 / 272some concern
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • inconclusive 2 % decrease in progression or deaths (PFS) (PE)
  • suggested 30 % decrease in deaths (OS) (extension)
  • demonstrated 1.1-fold increase in objective responses (ORR) (PE)
  • more...