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
atezolizumab alone
IMvigor-130 (At-arm B vs Ch-armC), 2020
  NCT02807636		RCTmUC - L1 - all populationatezolizumab (B)chemotherapy (C) gemcitabine plus platinepatients with untreated locally advanced or metastatic urothelial carcinoma360 / 400some concern
 inconclusive
  • inconclusive 2 % increase in deaths (OS) (PE)
  • statistically significant 62 % decrease in objective responses (ORR)
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)
durvalumab plus tremelimumab
DANUBE (DT vs C - all population), 2020
  NCT02516241		RCTmUC - L1 - all populationdurvalumab plus tremelimumabplatine based chemotherpyfirst line in Patients with Stage IV Urothelial Cancer.342 / 344some concern
 inconclusive
  • inconclusive 15 % decrease in deaths (OS) (PE)
  • statistically significant 41 % decrease in objective responses (ORR)
pembrolizumab plus SoC
KEYNOTE-361 (PC vs C), 2021
  NCT02853305		RCTmUC - L1 - all populationpembrolizumab plus chemotherapychemotherapy 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 cancer351 / 352some concern
 inconclusive
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • suggested 22 % decrease in progression or deaths (PFS) (PE)
versus placebo plus SoC
atezolizumab plus SoC
IMvigor-130 (At-arm A vs Pl-arm C), 2020
  NCT02807636		RCTmUC - L1 - all populationatezolizumab (A) plus gemcitabine and platineplacebo (C) plus gemcitabine and platinepatients with untreated locally advanced or metastatic urothelial carcinoma451 / 400some concern
 conclusif
  • inconclusive 17 % decrease in deaths (OS) (PE)
  • demonstrated 18 % decrease in progression or deaths (PFS) (PE)
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 - 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)
durvalumab plus tremelimumab
DANUBE (DT vs C - PDL1>25%), 2020
  NCT02516241		RCTmUC - L1 - PDL1 positivedurvalumab plus tremelimumabplatine based chemotherpy (SOC)first line in Patients with Stage IV Urothelial Cancer with PDL1 high expression level205 / 207some concern
 suggested
  • suggested 26 % decrease in deaths (OS)

 

- About us - Contact us - Method - RSS Made with in Lyon - Credits - Privacy policy - Licence Creative Commons