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)