Study study type PathologyT1T0Patientssample sizesROB Results

mBC - TNBC - L1 - all population breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - all population

versus placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-355 (all population), 2020
  NCT02819518
RCTmBC - TNBC - L1 - all populationPembrolizumab plus chemotherapyplacebo plus chemotherapypatients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (all population)566 / 281low
inconclusive
  • inconclusive 11 % decrease in deaths (OS) (PE)
  • suggested 18 % decrease in progression or deaths (PFS) (PE)
  • statistically significant 76 % decrease in objective responses (ORR)
OS results from ESMO Congres 2021

mBC - TNBC - L1 - PDL1 positive breast cancer - triple negative mBC - Triple negative (TNBC) - 1st Line (L1) mBC - TNBC - L1 - PDL1 positive

versus placebo plus SoC
pembrolizumab plus SoC
KEYNOTE-355 (CPS>1), 2020
  NCT02819518
RCTmBC - TNBC - L1 - PDL1 positivePembrolizumab plus chemotherapyplacebo plus chemotherapypatients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (PDL1 CPS>1)425 / 211low
suggested
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • suggested 25 % decrease in progression or deaths (PFS) (PE)
OS results from ESMO Congres 2021
KEYNOTE-355 (CPS>10), 2020
  NCT02819518
RCTmBC - TNBC - L1 - PDL1 positivePembrolizumab plus chemotherapyplacebo plus chemotherapypatients with with untreated locally recurrent inoperable or metastatic triple-negative breast cancer (PDL1 CPS>10)220 / 103low
conclusif
  • demonstrated 27 % decrease in deaths (OS) (PE)
  • demonstrated 34 % decrease in progression or deaths (PFS) (PE)
OS results from ESMO Congres 2021