Study study type PathologyT1T0Patientssample sizesROB Results

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

versus nab-paclitaxel, placebo
toripalimab
TORCHLIGHT, 2024
  NCT04085276
RCTmBC - Triple negative (TNBC) - 1st Line (L1)toripalimab 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)
  • statistically significant 73 % increase in SAE (grade 3-4)
TORCHLIGHT PDL 1 positive population, 2024
  NCT04085276
RCTmBC - Triple negative (TNBC) - 1st Line (L1)toripalimab 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.