Study study type PathologyT1T0Patientssample sizesROB Results

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

versus nab-paclitaxel plus placebo
nab-paclitaxel plus toripalimab
TORCHLIGHT, 2024
  NCT04085276
RCTla/mBC - TNBC - L1 - all populationtoripalimab and nab-paclitaxelplacebo and nab-PPatients aged at least 18 years with histologically confirmed TNBC, previously untreated or no more than one previous systemic chemotherapy regimen for stage IV or locally advanced TNBC that is not amenable to surgery353 / 178low
inconclusive
  • suggested 31 % decrease in deaths (OS)
  • suggested 23 % decrease in progression or deaths (PFS) (PE)

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

versus nab-paclitaxel plus placebo
nab-paclitaxel plus toripalimab
TORCHLIGHT PDL 1 positive population, 2024
  NCT04085276
RCTla/mBC - TNBC - L1 - PDL1 positivetoripalimab and nab-paclitaxelplacebo and nab-PPatients aged at least 18 years with histologically confirmed TNBC, previously untreated or no more than one previous systemic chemotherapy regimen for stage IV or locally advanced TNBC that is not amenable to surgery200 / 100low
conclusif
  • suggested 38 % decrease in deaths (OS)
  • demonstrated 35 % decrease in progression or deaths (PFS) (PE)
The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1-positive patients with metastatic or recurrent TNBC with an acceptable safety profile.