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
durvalumab alone
DANUBE (D vs C - all population), 2020
  NCT02516241
RCTmUC - L1 - all populationdurvalumabplatine based chemotherpy (SOC) cisplatine plus gemcitabinefirst line in Patients with Stage IV Urothelial Cancer.346 / 344some concern
inconclusive
  • statistically significant 64 % decrease in objective responses (ORR)

mUC - L1 - PDL1 positive metastatic/advanced UC (mUC) - 1st Line (L1) mUC - L1 - PDL1 positive

versus gemcitabine plus platin
durvalumab alone
DANUBE (D vs C - PDL1>25%), 2020
  NCT02516241
RCTmUC - L1 - PDL1 positivedurvalumabplatine based chemotherapy (gemcitabine)first line in Patients with Stage IV Urothelial Cancer whose tumours express high levels of PD-L1.209 / 207some concern
inconclusive
  • inconclusive 11 % decrease in deaths (OS) (PE)
  • statistically significant 59 % decrease in objective responses (ORR)