Study study type PathologyT1T0Patientssample sizesROB Results

es-BC - TNBC - NA - all population breast cancer - triple negative es-BC - Triple negatif (TNBC) - (neo)adjuvant (NA) es-BC - TNBC - NA - all population

versus placebo
pembrolizumab alone
KEYNOTE-522, 2020
  NCT03036488
RCTes-BC - TNBC - NA - all populationpembrolizumabplacebopreviously previously untreated, nonmetastatic disease, stage II or stage III, triple-negative breast cancer treated with paclitaxel and carboplatin, treated for neoadjuvant phase and an adjuvant phase;784 / 390low
conclusif
  • demonstrated 12.6-fold increase in pCR (PE)
  • suggested 37 % decrease in events or deaths (EFS) (PE)

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

mBC - TNBC - L2 - all population breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - all population

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-119 (all population), 2019
  NCT02555657
RCTmBC - TNBC - L2 - all populationPembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC)312 / 310some concern
inconclusive
  • inconclusive 3 % decrease in deaths (OS) (PE)
  • statistically significant 60 % increase in progression or deaths (PFS)
  • statistically significant 40 % decrease in DCR

mBC - TNBC - L2 - PDL1 positive breast cancer - triple negative mBC-Triple negative (TNBC) - 2nd Line (L2) mBC - TNBC - L2 - PDL1 positive

versus Standard of Care (SoC)
pembrolizumab alone
KEYNOTE-119 (PDL1 CPS>10), 2019
  NCT02555657
RCTmBC - TNBC - L2 - PDL1 positivePembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC) patients with PDL1 CPS> 10 only96 / 98some concern
inconclusive
  • inconclusive 22 % decrease in deaths (OS) (PE)
KEYNOTE-119 (PDL1 CPS>1), 2019
  NCT02555657
RCTmBC - TNBC - L2 - PDL1 positivePembrolizumabchemotherapy (single agent)patients with previously treated metastatic triple negative breast cancer (mTNBC) patients with PDL1 CPS> 1 only203 / 202some concern
inconclusive
  • inconclusive 14 % decrease in deaths (OS) (PE)
  • statistically significant 35 % increase in progression or deaths (PFS)