Study study type PathologyT1T0Patientssample sizesROB Results

endometrial cancer endometrial cancer

versus placebo plus SoC
atezolizumab plus SoC
AtTEnd, 2023
  NCT03603184
RCTendometrial canceratezolizumabplaceboWomen With Advanced/Recurrent Endometrial Cancer360 / 189NA
suggested
  • suggested 26 % decrease in progression or deaths (PFS)
Interim analysis of OS in all comers indicated a trend in favor for atezo, despite 45 (24.3%) placebo patients received immunotherapy as subsequent therapy. Second PFS and duration of response in the dMMR population confirmed the efficacy of atezo
dostarlimab plus soC
RUBY (part 1), 2023
  NCT03981796
RCTendometrial cancerdostarlimab (500 mg)placeboprimary advanced stage III or IV or first recurrent endometrial cancer245 / 249low
conclusif
  • demonstrated 31 % decrease in deaths (OS) (PE)
  • suggested 36 % decrease in progression or deaths (PFS) (PE)
durvalumab plus olaparib plus SoC
DUO-E (durvalumab follow by durvalumab and olaparib vs control arms) DUPLICATE, 2023
  NCT04269200
RCTendometrial cancerdurvalumabplaceboPatients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer241 / 239low
conclusif
  • suggested 41 % decrease in deaths (OS)
  • demonstrated 45 % decrease in progression or deaths (PFS) (PE)
durvalumab plus SoC
DUO-E (durvalumab then durvalumab alone vs control arms), 2023
  NCT04269200
RCTendometrial cancerdurvalumabplaceboPatients With Newly Diagnosed Advanced or Recurrent Endometrial Cancer238 / 239low
conclusif
  • demonstrated 29 % decrease in progression or deaths (PFS) (PE)
dostarlimab plus soC, niraparib
RUBY (part 2), 2024
  NCT03981796
RCTendometrial cancerdostarlimab (500 mg) followed by dostarlimab plus niraparibplaceboprimary advanced stage III or IV or first recurrent endometrial cancer-/-low
suggested
  • suggested 40 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
The PFS improvement with dostarlimab was observed in the overall patient population and in a subset of patients with mismatch repair–proficient (MMRp) or microsatellite stable (MSS) tumors, meeting the primary end point of the study. Data pertaining to overall survival (OS), a key secondary end point, are immature but will continue to be followed.
pembrolizumab plus SoC
NRG-GY018_dMMR, 2023
  NCT03914612
RCTendometrial cancerpembrolizumabplaceboMeasurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer. The patients were stratified into two cohorts according to whether they had mismatch repair–deficient (dMMR) or mismatch repair–proficient (pMMR) disease112 / 113low
conclusif
  • demonstrated 70 % decrease in progression or deaths (PFS) (PE)
press realease 03/2024 : OS 0.55 [0.25; 1.19] not indexed in the results due to lack of information on the timepoint for this analysis
NRG-GY018_pMMR, 2023
  NCT03914612
RCTendometrial cancerpembrolizumabplaceboMeasurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer. The patients were stratified into two cohorts according to whether they had mismatch repair–deficient (dMMR) or mismatch repair–proficient (pMMR) disease295 / 296low
conclusif
  • demonstrated 46 % decrease in progression or deaths (PFS) (PE)
press realease 03/2024 : OS 0.79 [0.53; 1.17]not indexed in the results due to lack of information on the timepoint for this analysis
versus Standard of Care (SoC)
avelumab plus SoC
MITO END-3, 2023
  NCT03503786
RCTendometrial canceravelumab SoCStandard of carehistologically confirmed advanced (FIGO stage III–IV) or recurrent endometrial cancer, an Eastern Cooperative Oncology Group (ECOG) performance status of 0–1, and no previous systemic anticancer therapy as primary treatment for advanced or metastatic disease63 / 62some concern
inconclusive
    no statistically significant result
pembrolizumab plus lenvatinib
LEAP-001/ENGOT-en9, 2024
  NCT03884101
RCTendometrial cancerpembrolizumab plus levitinibcarboplatine plus paclitaxelFirst-line Treatment of Advanced or Recurrent Endometrial Carcinoma-/-NA
inconclusive
  • inconclusive 7 % decrease in deaths (OS) (PE)
  • inconclusive 9 % decrease in progression or deaths (PFS) (PE)
lenvatinib in association, pembrolizumab plus lenvatinib
KEYNOTE-775, 2023
  NCT03517449
RCTendometrial cancerpembrolizumab plus lenvatinibPaclitaxel or DoxorubicinParticipants With Advanced recurrent or metastatic Endometrial Cancer. Eligible women had disease progression after the receipt of one previous platinum-based chemotherapy regimen411 / 416some concern
conclusif
  • suggested 35 % decrease in deaths (OS),deaths (OS) (PE)
  • demonstrated 44 % decrease in progression or deaths (PFS),progression or deaths (PFS) (PE)
  • suggested 44 % decrease in PFS (extension),PFS (extension)