Study study type PathologyT1T0Patientssample sizesROB Results

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
  • statistically significant 35 % increase in progression or deaths (PFS)
  • statistically significant 47 % decrease in objective responses (ORR)

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 % 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...

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 % decrease in deaths (OS) (PE)
  • inconclusive 11 % decrease in progression or deaths (PFS) (PE)