Study study type PathologyT1T0Patientssample sizesROB Results deaths (OS) Eprogression or deaths (PFS) ERFS/DFS E

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

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-361 (P vs C), 2021
  NCT02853305
RCTmUC - L1 - all populationpembrolizumabchemotherapy alone (cisplatine or carbo plus gemcitabine)patients with histologically or cytologically confirmed unresectable/metastatic urothelial carcinoma, who received no prior systemic chemotherapy for advanced urothelial cancer307 / 352some concern
inconclusive -8% 35%

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

versus Standard of Care (SoC)
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% -2%

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

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-045 (PDL1 CPS >10%), 2017
  NCT02256436
RCTmUC - L2 - PDL1 positivepembrolizumabchemotherapy (ICC)as second-line therapy in patients with advanced urothelial carcinoma that progressed during or after the receipt of platinumbased chemotherapy.=> only PDL1 CPS >10%74 / 90some concern
conclusif demonstrated-43% -11%