Study study type PathologyT1T0Patientssample sizesROB Results

mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive

versus pembrolizumab plus placebo
pembrolizumab plus ipilimumab
KEYNOTE-598, 2020
  NCT03302234
RCTmNSCLC - L1 - PDL1 positivepembrolizumab plus ipilimumabplacebo plus pembrolizumabas first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 with a tumor proportion score (TPS) ≥50% and no EGFR or ALK aberrations284 / 284low
inconclusive
  • inconclusive 8 % increase in deaths (OS) (PE)
  • inconclusive 6 % increase in progression or deaths (PFS) (PE)
versus pemetrexed plus platin
nivolumab plus ipilimumab
CheckMate 227 (NI vs C ; PDL1>1%), 2018
  NCT02477826
RCTmNSCLC - L1 - PDL1 positivenivolumab plus ipilimumabplatinium chemotherapypatients with histologically confirmed squamous or nonsquamous stage IV or recurrent NSCLC who had received no previous systemic anticancer therapy and PDL1>1%396 / 397some concern
conclusif
  • demonstrated 21 % decrease in deaths (OS) (PE)
  • suggested 18 % decrease in progression or deaths (PFS)
versus Standard of Care (SoC)
atezolizumab alone
IMpower-110 (TC2/3 or IC2/3), 2020
 
NCT02409342
RCTmNSCLC - L1 - PDL1 positiveatezolizumabplatinium chemotherapyPD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC2/3)166 / 162some concern
suggested
  • suggested 28 % decrease in deaths (OS),deaths (OS) (PE)
  • suggested 36 % decrease in PFS (extension),PFS (extension)
  • suggested 33 % decrease in progression or deaths (PFS),progression or deaths (PFS)
IMpower-110 (TC1/2/3 or IC1/2/3), 2020
  NCT02409342
RCTmNSCLC - L1 - PDL1 positiveatezolizumabplatinium chemotherapyPD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC 1/2/3)277 / 277some concern
inconclusive
  • inconclusive 17 % decrease in deaths (OS),deaths (OS) (PE)
  • suggested 28 % decrease in PFS (extension),PFS (extension)
  • suggested 23 % decrease in progression or deaths (PFS),progression or deaths (PFS)
IMpower-110 (TC3 or IC3), 2020
 
NCT02409342
RCTmNSCLC - L1 - PDL1 positiveatezolizumabplatinum chemotherapyPD-L1–selected patients (positive for PD-L1 on the SP142 assay) with EGFR and ALK wild-type metastatic NSCLC who had not previously received chemotherapy. (TC 3)107 / 98some concern
conclusif
  • demonstrated 41 % decrease in deaths (OS),deaths (OS) (PE)
  • suggested 41 % decrease in PFS (extension),PFS (extension)
  • suggested 37 % decrease in progression or deaths (PFS),progression or deaths (PFS)
cemiplimab
EMPOWER lung1 (PDL1>50%), 2021
  NCT03088540
RCTmNSCLC - L1 - PDL1 positivecemiplimabICCpatients with confirmed stage IIIB or IIICor stage IV squamous or non-squamous non-small-celllung cancer with PD-L1 expressed in at least 50% oftumour cells283 / 280some concern
suggested
  • suggested 43 % decrease in deaths (OS) (PE)
  • suggested 46 % decrease in progression or deaths (PFS) (PE)
durvalumab alone
MYSTIC (D ; PDL1>25%), 2020
  NCT02453282
RCTmNSCLC - L1 - PDL1 positivedurvalumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%163 / 162some concern
inconclusive
  • inconclusive 24 % decrease in deaths (OS),deaths (OS) (PE)
durvalumab plus tremelimumab
MYSTIC (DT ; PDL1>25%), 2020
  NCT02453282
RCTmNSCLC - L1 - PDL1 positivedurvalumab and tremelimumabplatinum-based doublet chemotherapyfirst-line treatment of patients locally advanced or metastatic NSCLC with PDL1 TC >=25%163 / 162some concern
inconclusive
  • inconclusive 15 % decrease in deaths (OS),deaths (OS) (PE)
  • inconclusive 5 % increase in progression or deaths (PFS),progression or deaths (PFS) (PE)
nivolumab alone
CheckMate 026 (PDL1>5%), 2016
  NCT02041533
RCTmNSCLC - L1 - PDL1 positiveNivolumabplatinum-based chemotherapypatients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC PD-L1 at >1%211 / 212some concern
inconclusive
  • inconclusive 15 % increase in progression or deaths (PFS) (PE)
CheckMate 026 (PDL1>1%), 2016
  NCT02041533
RCTmNSCLC - L1 - PDL1 positiveNivolumabplatinium doublet chemotherapypatients previously untreated had histologically confirmed squamous-cell or nonsquamous stage IV or recurrent NSCLC with PD-L1 >1%271 / 270some concern
inconclusive
    no statistically significant result
pembrolizumab alone
KEYNOTE-042 (PDL1>20%), 2019
  NCT02220894
RCTmNSCLC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapypreviously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 20% or greater413 / 405some concern
conclusif
  • demonstrated 23 % decrease in deaths (OS) (PE)
  • suggested 25 % decrease in deaths (OS) (extension)
KEYNOTE-042 (PDL1>1%), 2019
  NCT02220894
RCTmNSCLC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapypreviously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 1% or greater637 / 637some concern
conclusif
  • demonstrated 19 % decrease in deaths (OS) (PE)
  • suggested 20 % decrease in deaths (OS) (extension)
KEYNOTE-042 (PDL1>50%), 2019
  NCT02220894
RCTmNSCLC - L1 - PDL1 positivepembrolizumabplatinium based chemotherapypreviously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 50% or greater299 / 300some concern
conclusif
  • demonstrated 31 % decrease in deaths (OS) (PE)
  • suggested 2 % decrease in deaths (OS) (extension)
  • suggested 19 % decrease in progression or deaths (PFS)
KEYNOTE-024 (PDL1>50%), 2016
  NCT02142738
RCTmNSCLC - L1 - PDL1 positivePembrolizumabICC platinum-based chemotherapies regimenspatients who had previously untreated advanced stage IV NSCLC with PD-L1 expression on at least 50% of tumor cells154 / 151some concern
conclusif
  • demonstrated 40 % decrease in deaths (OS) (PE)
  • demonstrated 50 % decrease in progression or deaths (PFS) (PE)
  • suggested 38 % decrease in deaths (OS) (extension)
  • suggested 50 % decrease in PFS (extension)